Study to Evaluate Pharmacokinetics of Single Oral Doses of Formulated and Non-Formulated CC-122, and Food Effect Study
Status:
Completed
Trial end date:
2014-02-08
Target enrollment:
Participant gender:
Summary
The study is being conducted to compare how long 2 oral formulations (a reference and a test
formulation) of CC-122 stays in the body, and whether taking the test formulations with a
high-fat meal affects the absorption of that formulation. There will be 3 dosing periods in
the study, one for each formulation and one for the test formulation + meal. The subjects
will be asked to fast for at least 10 hours before taking the capsule formulations. During
one of the periods, the subject will be asked to eat a high-fat meal 30 minutes before being
given the capsule to swallow. Subjects will be randomly (by chance) assigned to a treatment
sequence which will determine the order in which the subject will receive the reference
formulation, the test formulation, and the test formulation + high-fat meal. Blood samples
will be taken at intervals during the study to assess the amount of drug at those time
points. Blood samples will also be collected at certain time points to determine the levels
of special proteins that may help explain how CC-122 work.