Clinical Results Summary
A clinical study to learn about the safety and effect of food on
the levels of Quizartinib in the blood of healthy participantsProtocol number: AC220-008

Thank You!

Daiichi Sankyo, Inc., the sponsor of this study, would like to thank the participants who
took part in this study for quizartinib, also known as AC220. Each participant helped toadvance medical research for people affected with acute myeloid leukemia. Their
contribution to medicine and healthcare is greatly appreciated.

Important note: This summary only shows the results of a single study. Other studies may have different
findings. Researchers and health authorities look at the results of many studies to understand which
treatments work and how they work. It takes a lot of people in many studies around the world to advance
medical science and healthcare.
Do not use the results of this study to make health decisions. Please talk to a doctor before changing any
treatment you are taking or if you have any questions about these study results.

What was the main purpose of this study?
Acute myeloid leukemia (AML)
Quizartinib, also known as AC220, is an investigational drug being tested for the treatment of acute myeloid
leukemia, or AML. Acute myeloid leukemia is a cancer of the blood and bone marrow.
Before a new drug can be given to patients, the researchers developing it perform many research studies toensure that the drug is safe and effective. The first step in studying a new drug is to test it in healthy people.
This means people without any health problems. This study involved healthy participants.
The presence of food in the stomach can affect how much of a drug that is taken by mouth is absorbed by thebody. In this study, researchers wanted to know if there is any effect of food on quizartinib levels in the bodywhen quizartinib is taken under fasted (no food present in the stomach) or fed (food present in the stomach)conditions. This will enable researchers to decide what dose of quizartinib should be given to people based on
their food intake.

Treatment given in this study
The treatment given in this study was:

Main purpose of this study

The main question the researchers wanted to answer in this study was:*The body breaks down quizartinib into another product called AC886. AC886 has similar effects in the body toquizartinib.
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Other purpose of this study
Researchers also wanted to answer the following question:•What side effects could the participants develop during the study?

There were some additional questions that researchers wanted to answer but these are not discussed in thissummary.

How long was this study?
An individual participant could have been in this study for 3
to 6 weeks.
The study started in August 2011 and ended in March 2012.
A study report was created. This summary is based on thatreport.

Who was in this study?
This study included 58 participants from the United States.

Participants could take part in this study if they were healthy individuals and:•were 18 to 50 years of age,•

had normal kidney and liver functions as measured by different blood tests, and•were using effective birth control methods during the study or were unable to have children.
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What happened during this study?
This was a Phase 1 study. Phase 1 studies are done to find out how new study treatment works in a small
number of healthy participants. This helps researchers understand what happens to the study treatment in
the body, and if there are any side effects.
This study was “open label”. This means that both the researchers and the participants knew which treatment
was given to which participants.
There were 2 situations in which the treatments were administered in the study:
Quizartinib administered without food (fasted conditions): participants fasted overnight for
10 hours and continued to fast for 4 hours after taking the study treatment
Quizartinib administered with food (fed conditions): participants fasted overnight for 10 hours andthen had a meal. Quizartinib was administered 30 minutes after the meal. Participants fasted for
4 hours after taking the study treatment.
Part 1: This part of the study was the dose selection part. It included 8 participants. Based on the results ofthis part, a higher or lower dose for the Part 2 was to be selected. Participants were randomly assigned to 1 ofthe 2 treatment arms (4 participants in each arm). On Day 1, 4 participants received a single dose ofquizartinib 20 mg solution by mouth under fed conditions and 4 participants received the same dose underfasted conditions.
Part 2: This part of the study included 50 participants. Participants were randomly assigned to 1 of the2 treatment arms (25 participants in each arm). On Day 1, 25 participants received a single dose of quizartinib
60 mg solution by mouth under fed conditions and 25 participants received the same dose under fastedconditions. The dose of quazirtinib was selected based on the analysis of Part 1 of the study.

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What were the key results of this study?
Key results from this study are shown for the total group of participants as average results. This summary does
not show the results from each individual participant. An individual participant’s results could be different
from the total group of participants. A full list of the questions the researchers wanted to answer, and adetailed presentation of the results can be found on the websites listed at the end of this summary.

What was the effect of food on the levels of quizartinib and its active breakdown
product AC886 in the blood of healthy participants?
To answer this question, the researchers collected blood samples from the participants at defined timepoints
over a period of time. They measured the levels of quizartinib and AC886 in the participants’ blood during thestudy.
However, the blood samples from this study were not properly processed. Therefore, it was not possible toaccurately measure the effects of food on the blood levels of quizartinib and its active breakdown productAC886. The effect of food on the blood levels of quizartinib was repeated in another study, AC220-019.

What were the other results of this study?
What side effects did the participants develop during the study?

Side effects are medical problems (this may range from something mild such as feeling tired or something
more severe like a severe infection or other medical problem) that happened during the study, which thestudy doctor thought could be related to the treatments in the study.

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Side effects are considered serious if they cause death, are life-threatening, cause disability, cause lasting
problems, cause birth defects, or require hospitalization. Some participants stopped study treatment becauseof side effects.
Side effects other than those related to quizartinib are not reported here. For more information on medicalproblems, please visit the websites listed at the end of this summary. The overall percentage (number) ofparticipants who had any side effects in any group are presented below:

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The most commonly reported side effects (part 1 and 2) are presented below:

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How was this study useful for patients and researchers?
This study was designed to help researchers understand the effect of food on the levels of quizartinib in bloodand its breakdown product AC886 in healthy participants. However, it was not possible to determine thisbecause of an issue with blood sample processing during the study.
Findings from this study may be used in other studies. Other studies for quizartinib are ongoing and thesponsor plans to conduct more studies in the future.
Please remember, this summary only shows the results of a single study. Other studies may have different
findings. Please talk to a doctor before changing any treatment you are taking or if you have any questions
about these study results.

Where can I learn more about this study?
If you were a study participant and have questions about the results of this study, please speak with the doctor
or staff at your study site.
Full study title: A Phase 1, Open-Label,randomized, Balanced, Single-Dose, Parallel
Design AC220 Food Effect Study in Healthy
VolunteersSponsor: Daiichi Sankyo, Inc.
Sponsor contact information:
211 Mount Airy Road, Basking Ridge, NJ 07920
Email: CTRInfo@dsi.com
Phone number: 1-908-992-6640
Date of this summary: 30 August 2022

This summary was prepared by Syneos Health®.

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