drugset / Trial / NCT03340662

Study Evaluating the Effects of Food, Cytochrome P450 Inhibition and Induction on the Pharmacokinetics of CC-122

NCT03340662

Phase 1 Completed 81 enrolled Celgene Corporation
RandomizedCrossoverOpen-labelTreatment

Summary

This is a phase 1 open-label 4-part study to evaluate the effect of food, cytochrome P450 inhibition and induction on the pharmacokinetics of CC 122 in healthy adult subjects. Approximately 81 subjects will be enrolled. There will be approximately 24 subjects in Part 1 and approximately 19 subjects in Parts 2, 3, and 4, respectively. Subjects may participate in 1 part only.

Timeline

Start
2017-11-09
Primary completion
2018-01-27
Completion
2018-01-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Avadomide Other / unclassified 3 mg Oral
Subject Fluvoxamine Unknown
Subject Itraconazole Small molecule
Subject Rifampin Small molecule

Indications

No indication recorded.