drugset / Trial / NCT03135509

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

Phase 1 Completed 16 enrolled Celgene Corporation
RandomizedCrossoverOpen-labelTreatment

Summary

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.

Timeline

Start
2017-05-24
Primary completion
2017-06-28
Completion
2017-06-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Iberdomide Small molecule 0.6 mg Oral

Indications

No indication recorded.