Healthy Participants Clinical Trial
Official title:
A Phase I, Open-label, Single-center Relative Bioavailability and Food Effect Randomized Crossover Study of New Granule and Capsule Formulations of Selumetinib (AZD6244) in Healthy Male Subjects
This study will evaluate bioavailability and food effect of selumetinib (AZD6244) in healthy male participants. A total of 24 healthy male participants will be included to ensure at least 20 evaluable participants. The study is divided in 2 study parts; the same participants will participate in both parts of the study. Part 1 of the study is to investigate the pharmacokinetics (PK) of the selumetinib granule compared to the PK of selumetinib capsule, when administered with water under the fasted conditions. Part 2 of the study is to investigate the PK of selumetinib granule and capsule under fed conditions. Participants will also receive a single 500 mg dose of acetaminophen at the same time as selumetinib administration.
This study will be a 2-part, open-label, single-center relative bioavailability and food
effect randomized crossover study of new granule and capsule formulations of selumetinib. A
total of 24 healthy male participants aged between 18 to 45 years (inclusive), will be
included to ensure at least 20 evaluable participants. The study is divided in 2 study parts;
the same participants will participate in both parts of the study.
Part 1 of the study is designed to investigate the PK of the selumetinib granule compared to
the PK of selumetinib capsule, when administered with water under the fasted conditions. Part
2 of the study is designed to investigate the PK of selumetinib granule and capsule under fed
conditions. Participants will consume a low-fat, low-calorie meal. Thirty minutes after the
start of the meal, selumetinib will be administered to the participants. In all treatment
periods, participants will also receive a single 500 mg dose of acetaminophen at the same
time as selumetinib administration where it will act as a marker for gastric emptying. The
study will also assess the palatability of the selumetinib granule in both parts of the
study.
Each participant will receive the following treatments:
- Treatment A: 25 mg granule, fasted state
- Treatment B: 50 mg capsule, fasted state
- Treatment C: 25 mg granule, fed state
- Treatment D: 50 mg capsule, fed state Participant will be randomly assigned to 1 of 4
treatment sequences. In all cases the treatments in Part 1 will be administered before
the treatments in Part 2. The study will comprise of a screening period of maximum 28
days. Four treatment periods during which participants will be resident from the day
before dosing (Day -1) until at least 48 hours after dosing; discharged on the morning
of Day 3. A follow-up visit, will be within 7 to 10 days after the last dose of
investigational medicinal product (IMP). There will be a minimum washout period of at
least 5 days between each IMP administration. Each participant will be involved in the
study for approximately 8 to 9 weeks.
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