Pharmacokinetics Clinical Trial
Official title:
A Phase 1, Open-label, Single-center Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibition and Induction on the Pharmacokinetics of CC-220 in Healthy Subjects
This is a two-part study to be conducted at a single study site in the US. Both parts of the
study may be conducted in parallel.
A total of approximately 38 subjects will participate in this study, with approximately 19
subjects in Part 1 and approximately 19 subjects in Part 2. Each subject may only
participate in one of the parts.
This is a two part study to be conducted at a single study site. Both parts of the study may
be conducted in parallel.
A total of approximately 38 subjects will participate in this study, with approximately 19
subjects in Part 1 and approximately 19 subjects in Part 2. Each subject may only
participate in one of the parts.
Each Part will consist of 2 study periods. Part 1 and Part 2, each subject will participate
in a Screening phase, one baseline visit per period, one dosing phase per period, and
follow-up telephone call.
In Part 1, subjects will receive a single dose of CC-220 in Period 1 and, following an
appropriate washout, multiple doses of itraconazole plus one dose of itraconazole with
CC-220 in Period 2. In Part 2, subjects will receive CC-220 in Period 1 and, following an
appropriate washout, multiple doses of rifampin plus one dose of rifampin with CC-220 in
Period 2.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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