A Study to Assess the Relative Bioavailability of a New CC-220 Capsule Formulation, Compared to a Reference CC-220 Capsule Formulation, in Healthy Adult Subjects

NCT03135509 PHASE1 COMPLETED

This is an open-label, randomized, 2-period, 2-way crossover study to assess the relative bioavailability of a new CC-220 capsule formulation, compared to a reference CC-220 capsule formulation, after administration of single oral doses in healthy adult subjects under fasted conditions. Approximately 16 subjects will be assigned randomly to 1 of 2 treatment sequences. The sequences will dictate the order in which each subject receives the following treatments: * Treatment A (Reference): A single dose of 0.6 mg CC-220, administered as two 0.3-mg formulated CC-220 gelatin capsules. * Treatment B (Test): A single dose of 0.6 mg CC-220, administered as one 0.6-mg formulated CC-220 Hydroxypropyl methylcellulose (HPMC) capsule.

Details

Lead sponsor	Celgene
Phase	PHASE1
Status	COMPLETED
Enrolment	16
Start date	Wed May 24 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Jun 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Healthy Volunteers

Interventions

• CC-220

Countries

United States