PRJ 2206 1 36

PARTICIPANT INFORMATION SHEET
Study Part A
Participant Information Sheet and Informed Consent Document

Full Study Title:
A Phase 1, Randomized, Single-Blind, Placebo-Controlled Study

to Assess the Safety, Tolerability and Pharmacokinetics of
AZD9977 Following Single Ascending Dose Administration to
Healthy Male Subjects
Simplified Study Title:
Study to Assess the Effects of Single Ascending Doses of

AZD9977 on Healthy Male Participants
Protocol Number:
EudraCT Number:
PAREXEL Number:
Sponsor:
D6400C00001
2015-000877-11
PXL219147
AstraZeneca AB
151 85 Sdertlje
Sweden
Principal Investigator:
Early Phase Clinical Unit:
Dr Muna Albayaty
PAREXEL Early Phase Clinical Unit (London)
Northwick Park Hospital
Watford Road
Harrow, HA1 3UJ
United Kingdom
Contact for participants:
Phone (office hours):

Nurses Station:
Phone (24-hour emergency):

Protocol Number: D6400C00001
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PAREXEL Number: PXL219147
Approved by NRES London Brent: 02 Jun 2015
01895 614 883

01895 614 890
07740 631 222
TP-EP.SCI-LO-001
Final 2.0 dated 01 June 2015
Page 1 of 20

Study Part A
1. Invitation to take part in research

You have been invited because you have indicated that you are willing to consider taking part as a
participant in research studies to examine the potential of new therapeutic drugs.
The study is divided into Part A and Part B. Separate groups of participants will be included in each
part of the study. This information sheet and consent form is intended for participants who will be
included in Part A.
This part of the study will recruit healthy, non-smoking males between the ages of 18 and 50 years
(inclusive). A total of up to 92 participants will take part in the study. Additional participants may be
enrolled if needed. There will be up to 80 participants in this part of the study (Part A).
You will not be able to take part in this study if you currently have, or suffer/have a history of any of the
following conditions or diseases:
Heart diseases including abnormal heart rhythms and abnormal electrocardiograms (ECGs)
Gastro Intestinal Tract conditions that may interfere with the absorption, distribution, metabolism
and excretion of medication
Weak liver, kidney or thyroid function, even if you show no symptoms
Hypersensitivity against the study medication, or excipients (other ingredients in the study
medication alongside the study drug).
Any condition requiring regular need for medication (e.g. diabetes, high blood pressure)
Any condition or disorder, which in the opinion of the Study Doctor, may put your health and safety
at risk or confound the results of the trial.
A list for restrictions that you will need to comply with during the study is listed in Section 8.
Before you decide to take part, it is important for you to understand why we are doing the research and
what it will involve. Please take time to read the following information carefully and discuss it with the
Study Doctor, friends, relatives and your General Practitioner (GP) if you wish. Ask us if there is
anything that is not clear or if you would like more information. Take time to decide whether you wish
to take part.
This study will take place at the PAREXEL Early Phase Clinical Unit (London) (referred to as the Unit
throughout the remainder of this document), Northwick Park Hospital, Watford Road, Harrow,
HA1 3UJ. Although based in a National Health Service (NHS) Trust Hospital, the Unit is independent
from the NHS. AstraZeneca (referred to as the Sponsor throughout the remainder of this document) is
the Sponsoring Company conducting this study.
If you are a vegan or if you have medical dietary restrictions, you will not be considered for
participation in this study. However, vegetarians may be included in this study.
**This is a first-time-in-human study, which means that this is the first time that the study drug
will be given to humans. **
** This study is for research purposes only and you will receive no medical benefit from taking
part. **

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Study Part A
2. What is the purpose of the study?

Before a new medicine can be approved for use in humans, it is necessary to confirm that it is safe
and effective. This is done by carrying out research studies (or clinical studies) such as this one.
The new medicine tested in this study is a compound called AZD9977 (referred to as the study drug
throughout the remainder of this document). The Sponsor is developing the study drug for treating
diabetic nephropathy (kidney disease resulting from diabetes complications) and related indications.
The main aim of this part of the study is to see how safe the study drug is and how well it is tolerated
after dosing. The study will also investigate how the study drug is taken up, metabolised (chemically
broken down), distributed through the body and excreted (this is known as pharmacokinetics [PK]).
3. Do I have to take part?

No. It is entirely up to you to decide whether or not to take part. If you prefer not to take part, you do
not have to give a reason. When you are satisfied, that you have been given enough information
about the study and if you do decide to take part, you will be asked to sign the consent form at the
back of this information sheet. We will give you a copy of the signed and dated information sheet and
consent form to keep.
If you decide to take part, you are still free to withdraw from the study at any time and without giving a
reason. This will not affect the standard of care you receive or your legal rights.
We will contact your GP for more information regarding your medical history before you start the study
to make sure that you are suitable to take part.
Please contact the Study Doctor should you decide not to participate in the study.
Should you decide to stop your participation during the study; the Study Doctor will explain the best
way for you to withdraw from the study. Likewise, the Study Doctor may decide that continuing
participation in the study is no longer in your best interest and you may be withdrawn.
If you stop taking part in the study, it is highly recommended to go through study withdrawal
procedures that are necessary for your safety.
If you withdraw from the study, we will destroy all your identifiable blood and urine samples, but we will
need to use the data collected up to the time of your withdrawal. After your withdrawal, no new data
from you will be entered into the database.
Your participation in the study may be stopped at any time for any of the following reasons:
If at any time, you feel that you no longer want to take part.
Failure to comply with the Study Doctors instructions.
Serious medical events that may require treatment or observation.
The Study Doctor decides it is in the best interest of your health and welfare to discontinue.
There are not enough participants in the study.
The Sponsor stops development of the study drug.
Please read your consent form carefully and if you have any questions please do not hesitate to ask.

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Study Part A
4. What is the drug that is to be tested?

The study drug does not yet have a name and it is not yet licensed. It is only known by the number
AZD9977. It is hoped that the study drug will be useful as a treatment for diabetic nephropathy and
other chronic kidney diseases.
This is a first-time-in-human study, which means that this is the first time that the study drug will be
given to humans. Up to now, it has only been tested in animals.
In this study you will receive (be dosed with) the study drug or placebo. A placebo is a dummy
treatment that looks like the study drug but has no active ingredients.
The term study medication will be used when referring to the study drug and/or placebo.
You will receive the study medication in the form of an oral suspension of 5 mg/mL, 25 mg/mL or 200
mg/mL. A dose range will be studied.
This study is for research purposes only and you will receive no medical benefit from taking part.
The study drug may or may not cause one or more of the following potential side-effects
(based on animal testing data):
Increased heart rate
Low blood pressure
Increased growth of cells in the walls of or around blood vessels in the heart.
Dizziness, light-headedness, headache, palpitations, feeling faint
Increase in liver enzymes
Increase in the blood levels of potassium (hyperkalaemia)
Dehydration
Increase in levels of uric acid in the blood (hyperuricemia)
Erectile dysfunction
Increased breast size in males
Painful breasts
Increased levels of sugar in the blood
There may be unknown side-effects which may be serious and unforeseen

The study has been designed to minimise and / or avoid any potential side effects to the
participant.
Please refer to Section 9, for a detailed description of the possible risk associated with the study drug.
The possible risk associated with the study procedures are discussed in detail in Section 10.

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Study Part A
5. What will happen to me if I take part?

This part of the study consists of 1 Screening Visit, 1 Treatment Period where you will be given a
single dose of study medication and 1 Follow-up Visit.
If you decide to take part, you will be asked to attend the Screening Visit up to 28 days before you
receive the dose of study medication.
In the Treatment Period, you will be admitted to the Unit on the night before dosing (Day -1) and be
required to stay in the Unit for 4 days and 3 nights. You will be dosed on Day 1 of the Treatment
Period and have assessments performed until 48 hours after dosing. You will be released from the
Unit on Day 3 if the Study Doctor is satisfied that you are in good health. You will then return for a
Follow-up Visit 5 to 7 days after your dose of study medication.
The total study duration for each participant will be approximately 5 weeks.
Participants will be divided into 8 groups (cohorts) with 8 participants per cohort (it may be necessary
to add another 2 cohorts as the study progresses).
Within your cohort, you will be randomised to receive a single dose of either the study drug or placebo.
In each cohort, 6 participants will receive the study drug and 2 participants will receive the placebo.
Your chance of getting the study drug is therefore 3 out of 4.
The process of deciding who gets study drug and who gets placebo is called randomisation (purely by
chance, like the tossing of a coin) performed by a computer. Neither you, Study Doctor nor the Clinical
staff will know what treatment you are getting. However, the Study Doctor will be able to find out this
information, if needed for any reason.
You will be required to refrain from consuming any foods or fluids other than water for at least 10 hours
before receiving the single dose of study medication. You will be required to fast for another 4 hours
after the dose. You will not be allowed to drink water for 2 hours before receiving the study medication
and for 2 hours after the dose (except for the water given to you to take the study medication). You
will be required to drink water at given intervals throughout the day. To standardise the water intake
for all participants 10 hours after dosing, no additional water intake will be allowed. During your stay at
the unit, you receive standardised meals, which will exclude alcohol and grapefruit containing
products.
In each cohort, the study drug will be given in increasing doses, but you will only receive one dose.
As a safety precaution, 1 participant will receive the study drug and 1 participant will receive the
placebo in the first dosing session with a suitable time apart and monitored for safety for 24 hours after
dosing. If you are in the first dosing session, your chance of getting placebo is 50%. The remaining
6 participants in the cohort will be dosed with a suitable time apart according to the randomisation
schedule. Five (5) participants will receive the study drug and 1 participant will receive the placebo, at
least 24 hours after dosing the first 2 participants. If you are in the second dosing session, your
chance of getting placebo is 16.6%. Participants will be selected to be in 1 of the 2 dosing groups
based on their availability for the study dates.
During the conduct of the study, a number of tests will be performed. On rare occasion, these tests
may reveal a pre-existing medical condition (that was present before the study) which might prevent
you from taking part in the study. If this happens, a member of the Units Medical staff will discuss it
with you in private and with your consent; you will be referred back to your GP for appropriate medical
management.

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Study Part A
A number of procedures and tests will be performed on you during the study. You may not be familiar
with all test or procedures. Please ask the study staff if you have any questions or concerns regarding
the test or procedures.
Genetic research:
Cells in your body contain a type of molecule called deoxyribonucleic acid, or DNA for short. DNA is
what your genes are made of. Genes are inherited and direct growth, development, and how the body
functions. For example, some genes control the colour of your hair or eyes. Scientists have learned a
lot about how genes work. There are many differences, or variations, in DNA from one person to
another. These variations may affect a persons chance of suffering from a particular disease or the
way a person responds to a particular medication. You are being asked to give a blood sample for
pharmacogenetic research that will determine part of the structure of your DNA and enable us
compare it to medical information about you.
If you have given consent for the generic research of this study, we will draw 10 mL of blood from you
on the first day of dosing. DNA will be extracted from your blood sample. In this process, most of the
original blood sample will be used up but a small amount will be kept as a backup in case of
problems in the testing of your DNA. We will not use this blood sample for other purposes.
6. Study Overview
Screening Visit
You will attend the Unit within the 4 weeks (28 days) before you receive the dose of study medication.
You will be asked to fast from all food and drink with the exception of water for at least 10 hours before
this visit. The following samples will be collected and assessments performed to determine if you are
suitable to take part in the study:
You will be seen by a Study Doctor who will discuss the study fully, answering any questions that
you may have. If you still want to take part, the Study Doctor will then ask you to sign the Consent
Form before any other procedure is performed.
We will take some personal details from you, including your date of birth.
A Study Doctor will take a full medical history, including all medications that you are currently
taking.
A physical examination will be performed, you will also be weighed and you height measured.
Vital signs including blood pressure and pulse rate will be measured.
An electrocardiogram (ECG) (recording of your hearts electrical activity) will be performed.
Blood samples will be collected for routine safety tests, including a high-sensitivity troponin T and
NT-proBNP test. You will also be screened for, hepatitis B, hepatitis C (viruses that cause
inflammation of the liver), and human immunodeficiency virus (HIV) antibodies (the virus that
causes acquired immunodeficiency syndrome acquired immunodeficiency syndrome [AIDS]).
These blood samples are collected to ensure that you are a healthy participant.
You will also provide a urine sample. This will be used for routine safety tests, as well as a test
for alcohol and drugs-of-abuse (including cannabis, amphetamines, barbiturates, benzodiazepines,
cocaine, opiates and cotinine a measure of smoking status).
Review of how you are feeling (whether you feel okay, different from normal or unwell) and any
medications you have taken.
Genetic consenting: You will also be informed about a voluntary DNA test (an optional blood
sample that may be used for DNA testing to understand why different people respond differently to
the same drug). For more details, please read the separate information sheet.

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Study Part A
Should any of the test results be out of the normal range as specified for this study, we may
sometimes ask you to return to the Unit and provide an additional sample for repeat testing. Specific
details about any repeat samples required will not normally be discussed over the telephone but will be
addressed when you attend the Unit.
The Screening Visit will take approximately 4 hours. This visit is designed to assess all potential study
participants and to ensure that the study is as safe as possible; therefore, it is important that you be in
good health at this visit.
One of the most common reasons for being rejected at screening is having elevated blood liver
function test results (sometimes called LFTs which measure your liver enzymes). Your LFTs are
raised by alcohol and by exercise, often for several days. This is why we ask you to please avoid
alcohol for at least 72 hours (3 days) and exercise for at least 24 hours (1 day) before the Screening
Visit, so we can assess your liver function properly.
If all of your Screening results are satisfactory, you may be invited to take part in the study. If you are
eligible we will contact you (not less than 1 day before your scheduled admission date) to confirm
whether you want to proceed to the next phase of the study.
Please note, however, that a place on the study cannot be guaranteed and that an invitation to be
screened does not oblige PAREXEL to include you, or to make any payments to you.
You may be asked to be a reserve participant, as we usually need to have additional participants on
standby in case of non-attendance, exclusion or last minute withdrawal. Reserve participants are
selected based on safety results, or where these are equal, the decision to include participants is
made by the PAREXEL Unit staff.
Reserves need only to stay in the Unit until dosing is completed. They will be paid for their time, and
can usually take part in or be screened for another study straight away. The usual practice is for
reserve participants to join the next group of the same study, to avoid having to be re-screened.
Study Visit
Treatment Period (Day -1 to Day 3)
You will arrive at the Unit at the arranged time on the day before you receive the dose of study
medication (Day -1). During your time in the Unit, the following samples will be collected and
assessments performed in each Treatment Period (unless otherwise specified):
A brief physical examination will be performed.

Your eligibility will be re-assessed.
Your vital signs including blood pressure and pulse rate will be measured before dosing and at
various time-points thereafter.
An ECG will be performed before dosing and at various time-points thereafter.
Your heart will be monitored by means of telemetry (a type of continuous ECG) for 4 hours the
day before administration of the study medication (Day -1) and from 30 minutes before dosing until
24 hours after dosing. The electrodes for telemetry will be positioned as not to interfere with the
electrodes for the other ECG.
On Day 1, you will receive the study medication in the form of an oral suspension.
You will have a cannula inserted for the purposes of blood sampling. A cannula is a small flexible
tube which when inserted into a vein is used to withdraw blood. This means that a needle would
not be needed each time a blood sample is required, unless the cannula becomes blocked, which
could then require additional needle sticks.
Blood and urine samples will be collected for routine safety tests at various time-points.

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Study Part A
Blood and urine samples will be collected to measure the amount of the study medication and
metabolites in your bloodstream and urinary tract at various time-points (PK blood samples). In
the event of any safety concerns, the PK samples will be used for laboratory safety analysis
A DNA blood sample will be collected prior to dosing. This is a voluntary sample and will only be
collected if you have given separate consent.
Blood and urine samples for biomarker testing (biomarker refers to a biological molecule used as
a marker for a substance or condition or process of interest) will be collected before administration
of study medication and at various time points after administration.
You will provide a urine sample that will be tested to ensure that you have complied with the study
restrictions (avoidance of alcohol/smoking/recreational drugs, etc.). Urine samples for routine
safety tests will be collected at various time-points.
Urine samples will be collected to measure the amount of the study medication that is excreted
You will be asked to complete a Taste Assessment Questionnaire.
If the Study Doctor is satisfied that you are in good health and that there are no safety concerns, you
will be discharged from the Unit after all assessments on Day 3 have been completed.
Follow-up Visit
You will return to the Unit 5 to 7 days after the dose intake for a Follow-up Visit. The following samples
will be collected and assessments performed:
A brief physical examination will be performed.
Your vital signs including blood pressure and pulse rate will be measured, you will have an ECG.
Blood and urine samples will be collected for routine safety tests.
You will receive a summary of the study results when the study ends. To allow for full analysis of all
participants data, this will be about 12 months after the last person completes their participation in the
study.
7. How much blood will be drawn?

The total amount of blood to be collected throughout this study (excluding repeat samples) will be
approximately 320.5 mL. This is less than the volume given as a single donation at the Blood
Transfusion Service (470 mL) and we do not foresee any ill effects from this. The total amount of
blood taken from you will not exceed 450 mL.
8. What do I have to do?

Your personal safety during the study is of primary importance to us. It is also important that we meet
the requirements of the protocol (study plan). To ensure your safety, we will need to check certain
things when you are admitted to the Unit as well as during the study.
The food and beverages you have during the study are also an important factor in ensuring your safety
and well-being during the study as certain foodstuffs may interact with the study medication. It is
therefore important that you stick to the diet that will be provided to you at the Unit. When you are
admitted for your stay with us, we will ask you to give all food articles in your possession (including
sweets and drinks) to the study staff.

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Study Part A
So that we can be sure that all of the above has been done, the staff will look in your personal
belongings on admission and may check again at any time during the study. We need your consent to
be able to do this and trust that you understand that we are taking care of you in every possible way.
You will always be present when the staff look through your belongings and there will always be 2 staff
members present when this is done.
If you take part in this study, you must act in accordance with the following restrictions:
You should not have taken part in a study within the last 90 days (3 months) (or longer, if the
time for your body to get rid of the study medication was longer than expected) either here
or at other sites.
You should not have received an investigational biological product/investigational drug/vaccine
within 90 days (3 months), or longer if the time for your body to get rid of the study medication was
longer than expected) before you receive your dose of study medication.
You should not take any medication at all from 14 days (2 weeks) before the dose of study
medication and until the end of the Follow-up Visit. You should not stop any regular prescribed
medication or discontinue any medication where necessary without first discussing this with your
doctor or the Study Doctor. The term medication includes herbal (including garlic extract and
herbal teas), homeopathic and traditional remedies, exercise and dietary supplements as well as
vitamins, minerals, anti-oxidants, eye/ear/nose drops and medicinal skin creams. You should also
not take St. Johns Wort at least 3 weeks before dosing and until after the follow up visit. A
substance does not need to be given by a doctor to be a medicine - please notify a Study Doctor
if it has been necessary to take any medication so that we can confirm whether or not this will have
any effect on your participation in the study.
You should not consume food or drink that contains alcohol from 72 hours (3 days) before each
study visit until after the Follow-up Visit. You must not have a history of drinking more than 21
units of alcohol per week within 12 weeks (3 months) before admission to the Unit (1 unit = 10 g
pure alcohol = 250 mL of beer [5%] or 25 mL of spirits [35%] or 100 mL of wine [12%]).
An Alcohol Tracker application is available for download to your PC desktop from the following link:
http://www.nhs.uk/Tools/Pages/NHSAlcoholtracker.aspx. There is also a Drinks Tracker for your
iPhone or iTouch available from: http://www.nhs.uk/Tools/Pages/iphonedrinks.aspx. These free
applications will calculate the units of alcohol in your drinks and help you keep track of your drink
over a period of time. It also provides feedback on your drinking with links to further information
about alcohol and your health.
You should not consume caffeine-containing foods and beverages (e.g., chocolate, coffee, tea,
cola, Red Bull) for 24 hours (1 day) before each study visit until after the Follow-up Visit. At other
times, participants should limit their caffeine intake to equivalent of 3 cups of coffee per day
(1 cup = 360 mL soda, 180 mL coffee, or 240 mL tea) for the duration of the study.
You should not consume products containing taurine or glucuronolactone (Red Bull, Reload,
Rockstar, Relentless, Monster, Cult, Vitamin Water, Starbucks Doubleshot, etc.) from 24 hours
(1 day) before each study visit and for the duration of your stay in the Unit. If applicable: However,
sports drinks containing only glucose and electrolytes (for example Lucozade) are allowed.
You should not consume products containing quinine (tonic water, bitter lemon, etc.) from 7 days
before each study visit and for the duration of your stay in the Unit.
You should not consume products containing cranberry, pomegranate, starfruit, grapefruit,
pomelos, exotic citrus fruits or Seville oranges (including marmalade and juices made from
these fruits) from 7 days before each study visit and for the duration of your stay in the Unit.
You should not consume foods containing poppy seeds (speciality breads, muffins, etc.) from
72 hours (3 days) before the Screening Visit and until the Follow-up Visit.
You will only be allowed decaffeinated beverages and standardised meals during your in-house
stay at the Unit.

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Study Part A
You should not have used any nicotine or nicotine-containing products (tobacco, cigarettes,
cigars, snuff, nicotine chewing gum or nicotine plasters, etc.) within 3 months of the Screening
Visit, and should not use any until after the Follow-up Visit.
You should not do any strenuous exercise (including sporting activities, such as cycling,
swimming, running and weight lifting) from 48 hours (12 days) before each study visit. You should
not start any new physical training or increase the intensity of your usual training during your
participation in the study. During your stay at the Unit, you will be allowed to take part in light
recreational activities (reading, watching television, walking, playing pool and computer games,
etc.).
You should not have donated one or more units (500 mL) of blood or had any significant blood loss
within in 90 days (3 months) before clinic admission on Day -1, or have donated plasma within 7
days before clinic admission on Day -1.
You must not donate sperm from the day of dosing and for 3 months after discharge from the Unit.
You must practice effective contraception methods with female partners to prevent pregnancy
from the day of dosing and for 3 months after discharge from the Unit. Please consult the Study
Doctor about acceptable methods of contraception.
You will receive a small information card (about the size of a credit card) that states the study
you are taking part in, you will need to carry this card with you. The card also lists a 24-hour
contact telephone number for advice about the study and your treatment.
Also please:
Notify a Study Doctor if you are unable, in any way, to follow the study procedures.
Notify a Study Doctor if you feel at all unwell at any time during the study. If this occurs while you
are not in the Unit, you must make every effort to contact the Study Doctor.
Notify a Study Doctor if you are required to take ANY OTHER MEDICATION during the study, for
example if your own doctor prescribes antibiotics for an infection. You should of course also
remind any doctors treating you that you are currently taking part in a clinical study.
Answer all study questions (including medical history) honestly, disclose all medications that you
are currently taking, and report any side effects.
If you are male and your partner misses her period or thinks she may be pregnant, you will notify
the study staff immediately.
Do not participate in any other research study without approval from the Study Doctor.
9. What are the side effects of any treatment received when taking part?
AZD9977
This is a first-time-in-human study. Dosing will start with a very low dose, which is considered safe
based on the available animal data, and we will carefully evaluate all data before proceeding to the
next dose group.
The study drug being tested may cause some side effects. You may experience none, some or all of
those given below because medicines and their possible side effects can affect individual people in
different ways. In addition, the study drug may involve risks that are currently unknown. The following
are side effects that are known to be associated with the study drug:
Increased heart rate

Low blood pressure
Increased growth of cells in the walls of or around blood vessels in the heart.
Dizziness, light-headedness, headache, palpitations, feeling faint.
Increase in liver enzymes

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Study Part A
Increase in blood levels of potassium (hyperkalaemia)

Dehydration
Increase in levels of uric acid in the blood (hyperuricemia)
Erectile dysfunction
Increased breast size in males
Painful breasts
Increased levels of sugar in the blood.
Note: The information above comes from animal experiments. It also includes common side effects
that can be expected from the same type of drug.
As with all drugs, there is a risk that a rare or previously unknown side effect will occur and we cannot
rule out the possibility that an unknown side effect may be life-threatening.
Extensive animal experiments have suggested that the study drug should be safe given in the doses
proposed in this study and no major medical side effects are expected. Animal experiments, however,
are not always exact indicators of what will happen when the product is given to a person, so you will
be monitored closely during the study for any sign of side effects. Some effects may be unpredictable.
From a safety point of view, you will only be given a single dose. The decision to give higher doses in
subsequent weeks will depend on the results of safety tests. You will receive a lower dose, than the
highest dose given in animal studies that did not cause side effects. During the study, we will be
monitoring you closely and taking safety blood samples. You will be informed if any clinically important
changes are seen and if it is required, we may need to stop the study or withdraw you from further
participation.
Please be aware that many drugs can cause a serious allergic reaction in certain individuals.
For example, penicillin and even aspirin can be life-threatening to some people. It is essential for this
reason that you are honest regarding your past medical history, to allow the Study Doctors to keep this
study as safe as possible.
*** Please tell the staff immediately if you do experience any side effects while participating
in this clinical study, however minor. ***
Serious adverse reactions and hospitalisation: Although all possible precautions are taken to
prevent serious adverse events (side effects), if such an event occurs, it may be in your best interest to
be admitted to hospital. Depending on the type of event, we will contact a medical specialist to be
primarily responsible for your treatment. We will provide assistance to the hospital and doctors looking
after you, but all hospital records are confidential and for this reason we are asking you to give us, and
any emergency medical specialists we contact, consent to visit you and have access to your medical
records.
10. What are the other possible disadvantages and risks of taking part?
Venous blood samples: You will have blood collected from a cannula (flexible plastic tube) that will
be inserted in a vein in your arm. This minimises the use of needles, though sometimes (if the cannula
becomes blocked) a new cannula may need to be inserted or the use of a needle may be necessary.
You may experience minor discomfort from these procedures and occasionally some bruising or
irritation of the veins used for blood sampling. These effects normally clear up completely in a few
days.
Electrocardiogram: You may experience slight skin irritation from the adhesive on the ECG
electrodes, but this is generally mild and clears up within a few days.
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Study Part A
Anaphylactic reaction: In extremely rare cases, an anaphylactic reaction (a severe reaction
throughout the body that is recognised by difficulty in breathing, fainting, itching and wheals) may
develop after a few seconds or minutes, which may lead to death. For this reason an emergency kit
with a ready for use adrenaline syringe will always be available at the Unit. Tell the doctor or nurse
immediately if you feel any of the abovementioned reactions.
Private medical insurance: If you hold private medical insurance, you are advised to check with the
company who provides this insurance before agreeing to take part. This is to make sure that you will
not affect your medical insurance by being in a clinical study.
Harm to the unborn child/Contraception Requirements
You must be willing to follow the contraception (birth control) guidelines provided below in order to take
part in this study.
If you are surgically sterilized or not, and have a female partner of childbearing potential, you must
use a condom when having heterosexual intercourse, from the time you sign the consent form until 3
months after your last dose of the study medication.
If your partner becomes pregnant while you are participating in this study or in the 3 month period
afterwards, there may be risks to the unborn baby. There may also be risks associated with your
partner nursing (breastfeeding) a baby while you are participating in this study. Nobody knows what
these risks are and some drugs can cause babies to be born prematurely (earlier than they should be)
or to have birth defects.
Please share this information below with your partner if it is appropriate.
It is not known if the study drug will affect sperm or semen and therefore you must not father a child,
not donate sperm or have unprotected sexual intercourse with pregnant or breastfeeding women
during this study or for a safety period of 90 days (3 months) after the dose of study medication.
If your partner is of childbearing potential (able to have children) or if she has very recently had a tubal
ligation without oophorectomy and she is taking a hormonal contraceptive, she may choose to
continue taking the hormonal contraceptive but between the two of you, you should add 1 nonhormonal method of contraception (i.e., male condom with spermicide, female condom, diaphragm
with spermicidal jelly or a cervical cap). You and your partner must use reliable forms of contraception
during the study and for 3 months after the dose of study medication.
For participation in the study, the following methods of contraception are permitted:
Oral contraceptive + condom with spermicide

Coil or intra uterine device (IUD) + condom with spermicide
Diaphragm with spermicide + condom with spermicide
Injectable progesterone + condom with spermicide
Subdermal implants + condom with spermicide
True abstinence: When this is in line with your preferred and usual lifestyle. Periodic abstinence
(e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not
acceptable methods of contraception.
Male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in
the ejaculate).
If your partner becomes pregnant during the study or within 90 days (3 months) after the dose of study
medication you should inform the Study Doctor immediately. As the risk to your partner and baby is
unknown, your partner should agree to a follow up during her pregnancy and for the baby after it is
born. This is done for the safety of your partner and child, as well as for clinical data. The Study
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Study Part A
Doctor will work with the Sponsoring Company to organise this. Your partner will be invited to sign a
consent form to allow a pregnancy follow-up. The Sponsoring Company may also request you and
your partners consent to collect confidential information about her health and that of the baby.
11. What happens to any samples I give?

The blood and urine samples collected will be sent to a central laboratory to be analysed and the
Study Doctor will be informed of the results. The samples will be identified by a code number and not
by name and therefore it will not be possible for anyone other than the Study Doctor or other
authorised staff at the Unit to find out who the sample is from. Blood and urine samples collected for
routine safety tests will be destroyed after they have been analysed.
PK and biomarker blood and urine samples may be kept for future research for up to 15 years. The
sponsor undertakes to use your samples within the context of this clinical research study and to
destroy them at the end of the scheduled storage period. The research on your samples may begin at
any time during the study or during the post-study storage period and will be used to understand
AZD9977 better, to perform or develop tests or assays related to the study drug and/or the diseases
for which AZD9977 is being developed.
Stored samples will be coded throughout the sample storage and analysis process and will not be
labelled with personal identifiers. Participants may withdraw their consent for their samples to be
stored for research.
You will be informed if testing on your samples for this study will change.
12. What if there is a problem?

As the study drug is a new drug, there may be side effects that have not yet been recognised.
Sometimes during the course of a research project, new information becomes available about the
treatment/drug that is being studied. If this happens, the study staff will tell you about new information
that may be relevant to your participation in the study. If you decide to continue in the study, you will
be asked to sign an updated consent form, which will document any new information.
In the event of you suffering any bodily injury caused directly by your participation in the study,
compensation will be paid to you by AstraZeneca (the Sponsor) without you having to prove that the
injury arose through negligence or that the study drug was defective as set forth in the Association of
the British Pharmaceutical Industry (ABPI) guidance document Insurance on the Event of Injury in
Phase I Clinical Trials.
This compensation will be valid where the injury probably resulted from:
A drug being tested or administered as part of the study protocol.

Any test or procedure you received as a part of the study.
Negligence of the Study Doctor.
If your health or wellbeing deteriorates significantly as a result of taking part in this study, you will
be compensated by the Sponsor.
Any payment would be made without legal admission.

Your rights to compensation may be affected if:
You fail to disclose to the Study Doctor or deputy any relevant information that may affect your
participation in this study.
You fail to adhere to the requirements of the study.

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Study Part A
The amount of compensation should be calculated by reference to the amount of damages that would
commonly have been awarded for similar injuries by an English court had liability been proven. The
amount of compensation may be reduced if you are partly responsible for the injury or if you are
separately compensated under any other insurance policy by the Sponsoring Company for your
benefit.
The Sponsor and you as the volunteer should agree to refer any dispute about whether compensation
is payable or about the amount of such compensation to an arbitrator with power to consult a barrister
of 10 years standing on any issue of law, including the amount of damages to be paid. If the Sponsor
and you as the volunteer cannot agree on the identity of an appropriate arbitrator, the President of the
Royal College of Physicians of London will be invited to appoint an arbitrator.
The undertaking to compensate you as the volunteer will be construed in accordance with English law
and, participant to the provisions above, the English courts have sole jurisdiction over any dispute,
which may arise out of it.
There can be no guarantee that this level of indemnity will cover every conceivable set of
circumstances, but the relevant level is viewed as reasonable, particularly as the requirement for
insurance is only additional protection for you.
Should you suffer injury either during or after the study, and believe it to be a result of your
participation, please contact the Study Doctor or PAREXEL Unit medical staff at the earliest
opportunity. They will provide you with appropriate advice.
Should you need more information, you may ask to receive a copy of the relevant Association of the
British Pharmaceutical Industry (ABPI) guidelines. You may also contact the ABPI for assistance in
identifying who may be able to help you in assessing the validity of a possible claim or to further
progress a claim:
Association of the British Pharmaceutical Industry Tel: 08708 904 333
For further information, you may also visit the ABPI website www.abpi.org.uk
13. Complaints
Complaints can be raised at any time to the staff at PAREXEL (Tel 01895 614 851). However, if you
have concerns that cannot be resolved at the Unit, you can contact the Senior Management at
PAREXEL (Principal Investigator, Dr Muna Albayaty, Tel 01895 614 592 or Enrolment Services
Manager, Edward Knotwell, Tel 01895 614 779). All cases will be investigated and any findings
treated with respect.
14. What are the possible benefits of taking part?

This study is for research purposes only and as a healthy participant, you will receive no direct medical
benefit from taking part in this study. However, the information that we get from this study may be
helpful in treating patients with diabetic nephropathy in the future.
15. What happens when the research study stops?

The results from the study may be presented to regulatory agencies, at meetings and in publications.
However, your name or any information that identifies you will not be mentioned in any of those
presentations.

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Study Part A
16. Expenses and payments

If you are suitable to participate and are dosed, your involvement in the study will not be considered
complete until all follow-up blood, urine or other similar test results are acceptable. It is only when your
involvement is complete that payment in relation to your participation in the study will be made to you.
We will compensate you for your time and inconvenience (which includes travel expenses and
compensation for any lifestyle restrictions) to the sum of 1,030. This will be paid to you upon
completion of the study and this payment includes (that is, will not be increased) one additional visit for
repeat testing after the study has begun. Any additional unplanned visits above this, however, will be
paid at a rate of 30 per additional visit. You will not receive any additional payments for repeat
blood and urine safety tests required after the Screening Visit.
Please note: This additional payment may be forfeited (lost) if the repeat was necessary due to
non-compliance with study restrictions (because of exercise or alcohol use, for example).
Taking part in this study is entirely voluntary and we do not advise you to neglect other responsibilities
in order to attend the Unit. If you have to take time off work to attend the Unit, please make the
appropriate arrangements with your employer.
Please Note: The study is not completed until the results of your final follow-up blood/urine test are
considered acceptable.
You will not be paid for attending the Screening Visit and attending this visit will not automatically
guarantee you a place on the study.
Occasionally, study dates may change due to unforeseen events. In such a case, we will make
every effort to inform you as soon as possible.
If you are dosed with study medication but withdraw from the study before completion, you will be
paid on a proportional basis depending on the length of time you have taken part in the study.
If the Study Doctor decides it is in the best interest of your health and welfare to discontinue due to
medical reasons, you will be paid in full.
You should be aware that your study payment will be reduced if you fail to comply with any of the
restrictions specified above or break any of the Units rules. The payment reduction will be made
at the discretion of the study staff, and may amount to 10% per offence. A copy of these rules may
be provided to you at your Screening Visit and is posted on notice boards within the Unit.
If you attend the Unit as a reserve participant and are not subsequently dosed you will receive
225.
The payment will be made in the form of a crossed cheque that must be payable in your name
(which will be spelt as it appears in your identification documents). You are responsible for paying
tax on it if appropriate to your circumstances and for communicating this additional income/capital
to authorities who may be paying you social security benefits such as housing benefit, for example.
Please note that you will be liable for any cancellation charges incurred (brought about) for lost
cheques.
It is vital that you adhere to the requirements stated in this information sheet. In particular, if your urine
tests positive for drugs-of-abuse or you deliberately disregard any instructions given to you during the
study period, you may be asked to leave the study and will not be invited to take part in future studies.
Furthermore, part of the payment will be deducted as a penalty.

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Study Part A
17. Will my taking part in this study be kept confidential?

We will follow ethical and legal practices and all information about you will be handled in confidence.
Your GP will be told about your intention to participate in this study and will be asked to provide us with
information about your past medical history. Apart from this exception, all the information about your
participation in this study will be kept confidential.
PAREXEL staff will collect personal information about you. This will include information about your
health and your demographic details (such as your date of birth, your sex and your ethnic origin). By
signing this form, you consent to the Study Doctor and his or her staff collecting and using personal
data about you for the study. The Sponsoring Company may use Study Data to conduct the Study, to
support applications for approval of the study medication and for research related to the development
of pharmaceutical products, diagnostics or medical aids. The Study Doctors institution and the
Sponsoring Company are each responsible for their handling of Study Data in accordance with
applicable Data Protection law(s).
When your Study Data is processed in Sweden by the Sponsoring Company, AstraZeneca AB is
responsible for your personal data.
The Sponsoring Company and PAREXEL International Limited are legally obliged to inform you of the
following:
1. Throughout this study, the Study Doctors and nurses will record information about you in a
database known as an electronic case report form or eCRF. Sometimes, case report forms can
be paper. All information entered into the eCRF may be identified by a participant number, not
your full name. However, your full name and photograph are stored in the PAREXEL recruitment
database.
2. Information collected about you for the study will be processed by us and may be included in
reports which will be submitted to authorities (either in the United Kingdom or in any other country
in the world) so that one day the study drug may be available to all patients suffering from the
illness this drug treats. Authorised representatives of the sponsor may also observe study
procedures such as dosing. As part of the data processing, your information may also be passed
to authorised personnel within:
AstraZeneca and its group of companies

PAREXEL International Limited and its group of companies
Other authorised companies involved in reviewing or processing study data or for study and
non-study related activities.
Other companies within the Sponsors group, such as, service providers, contractors, research
institutions, and research based commercial organisations who will use Study Data only for the
purposes described above
Regulatory authorities
Ethics Review Committee
3. Some of the countries to which your information may be passed may not have the same level of
data protection as the United Kingdom (for example outside the EU), in accordance with the
applicable laws. All reasonable steps will be taken by us to protect your information and all data
will be pseudonymised/coded. The procedures for handling, processing, storage and destruction
of your data within PAREXEL are compliant with the Data Protection Act 1998.
4. Your information will only be used for the purposes stated above as explained to you by Dr Muna
Albayaty the Principal Investigator (main Study Doctor), or her deputy, and will be kept no longer
than necessary and (unless required by law) will not be disclosed to people other than those
mentioned above.
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Study Part A
5. If you withdraw your consent, the Study Doctor will no longer use Study Data or share it with
others. The Sponsoring Company may still use Study Data that was shared with it before you
withdrew your consent.
6. You have certain rights, which may allow you to have access to data held about you, and to object
or prevent certain processing of your information if it will cause you damage or distress.
For further details on your rights and how you can enforce them, you should contact the Data
Protection Registrars office (now known as The Office of the Information Commissioner, Executive
Department, Water Lane, Wycliffe House, Wilmslow, Cheshire SK9 5AF, www.ico.gov.uk).
7. A description of this clinical study will be available on http://www.ClinicalTrials.gov. This Web site
will not include information that can identify you. At most, the website will include a summary of
the results. You can search this website at any time.
If you are a UK citizen, your National Insurance (NI) number and photograph (from your passport or
UK driving licence) will be entered into our database. If you are not a UK citizen, your passport
number and country of origin and your photograph will be entered into our database. If you go on to
take part in a study, the date on which you receive your final dose of study medication will also be
entered.
The over-volunteering prevention service (TOPS) is a database that aims to prevent healthy volunteers
from taking part too often in studies of new medicines and is used by most other organisations carrying
out medical research studies in the UK. We will enter into the database: your NI number (if you are a
UK citizen); or your passport number and country of origin (if you are not a UK citizen); and the date of
your final dose of study medication. If you withdraw from the study before you receive any study
medication, the database will show that you never received a dose. Only staff at PAREXEL and other
clinical research units can use the database. We may contact other units, or they may contact us, to
check your details and we may discuss your participation in one of our studies with them, in order to
assess your level of participation in previous clinical studies. These measures are intended to prevent
you from being harmed by taking part in too many studies.
18. Contact details for further information

In case of a study-related injury or whenever you have questions about the study or the study
medication, please contact:
Recruitment and Screening Coordinators
Tel: 01895 614 883*

(For General Information and Enquiries)
Dr Muna Albayaty
Tel: 01895 614 592

(Main Study Doctor)
Emergency 24-hour contact
Tel: 07740 631 222
(For Medical Emergencies)

* These telephone numbers are direct lines and, if there is no answer, you should wait until you are
connected to the voice-mail system and leave a message (including a contact number). Your call will
be returned as soon as possible.
If you have chosen to use the Unit number and are not contacted within 24 hours please telephone:
01895 614 851. This number connects you to reception during office hours and to a voice-mail system
after hours. If you have chosen to call the emergency 24-hour mobile number, this is of course
constantly held by one of the doctors, and will always be answered immediately.

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Study Part A
19. Who is organising and funding the research study?

A pharmaceutical company called AstraZeneca funds this research. The Sponsor will pay for the costs
of the research, for example supply of study medication and the costs of laboratory tests to be
performed. They will also pay the PAREXEL Unit for conducting this study. The Study Doctor has no
financial interest in the Sponsoring Company or in the outcome of this study.
20. Who has reviewed the study?

The National Research Ethics Service (NRES) and the Medicines and Healthcare Products Regulatory
Agency (MHRA) have reviewed this study and they have agreed that it can go ahead.

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PARTICIPANT CONSENT FORM

Study Part A
Participants PAREXEL ID Number:
_____/_____/_____
(day/month/year)
Study Title: Study to Assess the Effects of Single Ascending Doses of AZD9977 on Healthy Male
Participants
Name of Study Doctor: Dr Muna Albayaty
Sign
I confirm that:
Statement
Participants Initials:
Participants Date of Birth:
I have read and understand the above participant information sheet (pages 1 18) for this study.
I have had the opportunity to consider the information, ask questions and have had these
answered satisfactorily.
I have read and understand the information sheet relating to blood borne viruses (HIV ,
hepatitis B and hepatitis C) (dated 29 April 2014) and consent to be tested for these viruses.
I agree that one of the Study Doctors will contact my General Practitioner (GP) and I authorise
my GP to divulge any information relevant to my suitability to take part in this study.
I understand the possible side effects and risks of the drug and procedures being tested in this
study.
It has been explained to me that the drug and procedures being tested may involve risks to me
that are currently unknown and that an unexpected or allergic reaction could take place that could
be life-threatening.
I understand that my PK and biomarker samples may be stored for up to 15 years to be used for
future research.
I agree that, in case of a rash, pictures of the rash area may need to be taken, and that these
pictures may be forwarded to the Sponsor and may be subject to future publications
(anonymously). I understand that I will not be personally identifiable on those pictures
I understand that all blood and urine samples for safety tests collected from me during the study
will be destroyed after they have been analysed.
I have read and understand the information on the contraception requirements and I agree to
follow these measures during this study and for the required safety period after my dose of study
medication.
I agree to comply with study restrictions and consent to bag searches by study staff.
I have read and understand the compensation arrangements for this study.
I understand that having signed the consent form, my participation is voluntary and that I am free
to withdraw at any time without giving a reason, and without my medical care or legal rights being
affected.
I understand that my photograph and a photocopy of my passport or UK driving licence will be
stored on the PAREXEL database for identification purposes.
I understand that I will receive a summary of the study results when the study ends.
I agree that my passport/national insurance numbers can be entered into the over-volunteering
prevention system (TOPS).
Should an event occur that requires my admittance to hospital, I give consent for the PAREXEL
medical staff and emergency medical specialists to visit me in the hospital and view my medical
records.
I agree that my personal data may be used as described in this consent form, including the
transfer of my personal data, including sensitive data, to the Sponsor and to regulatory authorities
both within and outside of the European Union (EU), and understand that this may be sent to
countries that do not have the same level of data protection as the EU.
I agree to take part in the above study, which is being conducted on behalf of AstraZeneca.

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Page 19 of 20
PARTICIPANT CONSENT FORM

Study Part A
_______________________________
Name of Participant
(Print full name including middle name)
_______________________
____/_____/20____
_____:_____
Signature
Date (day/month/year)
Time (24h clock)
________________________________
Name of Doctor Taking Consent
_______________________
Signature
____/_____/20____
Date (day/month/year)
_____:_____
Time (24h clock)

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PARTICIPANT INFORMATION SHEET

Participant Information Sheet and Informed Consent Document

A Phase 1, Randomized, Single-Blind, Placebo-Controlled Study

Simplified Study Title:

Study to Assess the Effects of Single Ascending Doses of

Contact for participants:

Phone (office hours):

Participant Information Sheet and Informed Consent Document

01895 614 883

PARTICIPANT INFORMATION SHEET

1. Invitation to take part in research

Participant Information Sheet and Informed Consent Document

PARTICIPANT INFORMATION SHEET

2. What is the purpose of the study?

3. Do I have to take part?

Participant Information Sheet and Informed Consent Document

PARTICIPANT INFORMATION SHEET

4. What is the drug that is to be tested?

Increased heart rate

Low blood pressure

Dizziness, light-headedness, headache, palpitations, feeling faint

Increase in liver enzymes

Increase in the blood levels of potassium (hyperkalaemia)

Increase in levels of uric acid in the blood (hyperuricemia)

Increased breast size in males

Increased levels of sugar in the blood

There may be unknown side-effects which may be serious and unforeseen

Participant Information Sheet and Informed Consent Document

PARTICIPANT INFORMATION SHEET

5. What will happen to me if I take part?

Participant Information Sheet and Informed Consent Document

PARTICIPANT INFORMATION SHEET

Participant Information Sheet and Informed Consent Document

PARTICIPANT INFORMATION SHEET

A brief physical examination will be performed.

Participant Information Sheet and Informed Consent Document

PARTICIPANT INFORMATION SHEET

7. How much blood will be drawn?

8. What do I have to do?

Participant Information Sheet and Informed Consent Document

PARTICIPANT INFORMATION SHEET

Participant Information Sheet and Informed Consent Document

PARTICIPANT INFORMATION SHEET

Increased heart rate

Participant Information Sheet and Informed Consent Document

PARTICIPANT INFORMATION SHEET

Increase in blood levels of potassium (hyperkalaemia)

PARTICIPANT INFORMATION SHEET

Oral contraceptive + condom with spermicide

PARTICIPANT INFORMATION SHEET

11. What happens to any samples I give?

12. What if there is a problem?

A drug being tested or administered as part of the study protocol.

Any payment would be made without legal admission.

Participant Information Sheet and Informed Consent Document

PARTICIPANT INFORMATION SHEET

14. What are the possible benefits of taking part?

15. What happens when the research study stops?

Participant Information Sheet and Informed Consent Document

PARTICIPANT INFORMATION SHEET

16. Expenses and payments

Participant Information Sheet and Informed Consent Document

PARTICIPANT INFORMATION SHEET