Healthy Volunteer Clinical Trial
Official title:
A Phase 1, Randomized, Parallel-Group, Open-Label Study to Evaluate the Effect of the Modulators of the Cytochrome P450 (CYP) 2C8 and/or 3A on the Single-Dose Pharmacokinetics of Ozanimod and CC112273 in Healthy Adult Subjects
The purpose of this study is to evaluate the effect of the following index inhibitors or
inducers of CYP2C8 and/or CYP3A on the single-dose pharmacokinetics (PK) of ozanimod and its
major active metabolite, CC112273, in healthy adult subjects: gemfibrozil (strong inhibitor
of CYP2C8), rifampin (moderate inducer of CYP2C8 and strong inducer of CYP3A), and
itraconazole (strong inhibitor of CYP3A).
Study Design
This is a Phase 1, randomized, parallel-group, open-label study with two parts, 1 and 2.
Forty subjects will be enrolled in Part 1 and will be randomized into 1 of the 2 treatment
groups, with 20 subjects in each treatment group. Sixty subjects will be enrolled in Part 2
and will be randomized into 1 of the 3 treatment groups, with 20 subjects in each treatment
group. . Study parts and treatment groups are as follow:
Part 1:
- Treatment Group A (reference): A single dose of ozanimod.
- Treatment Group B (test): Gemfibrozil 600 mg twice daily (BID) on Days 1 through 17. On
Day 4, a single dose of ozanimod will be coadministered with the morning dose of
gemfibrozil.
Part 2:
- Treatment Group C (reference): A single dose of ozanimod.
- Treatment Group D (test): Itraconazole 200 mg once daily (QD) on Days 1 through 17. On
Day 4, a single dose of ozanimod will be coadministered with itraconazole.
- Treatment Group E (test): Rifampin 600 mg QD on Days 1 through 21. On Day 8, a single
dose of ozanimod will be coadministered with rifampin.
Study Population Subjects will be healthy men and non-pregnant, non-lactating women, ages 18
to 55 years, inclusive, with a body weight of at least 110 pounds (50 kg); body mass index
(BMI) within the range of 18.0 to 30.0 kg/m2, inclusive.
Length of Study The study duration ranges from 43 days to 50 days.
n/a
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