NCT01707407 — drugset

Summary

1. To evaluate the pharmacokinetics (PK) of pomalidomide administered with the CYP3A4/P-gp inhibitor ketoconazole compared with pomalidomide alone in healthy male subjects. 2. To evaluate the PK of pomalidomide administered with the CYP3A4/P-gp inhibitor ketoconazole plus the CYP1A2 inhibitor fluvoxamine compared with pomalidomide alone in healthy male subjects. 3. To assess the PK of pomalidomide administered with the CYP1A2 inhibitor fluvoxamine and the CYP3A4/P-gp inhibitor ketoconazole compared with pomalidomide plus the CYP3A4/P-gp inhibitor ketoconazole in healthy male subjects. Part 2 1\) To evaluate the pharmacokinetics of pomalidomide administered with the CYP3A4 inducer carbamazepine compared with pomalidomide alone in healthy male volunteers. Secondary Objectives 1\) To evaluate the safety of pomalidomide in Part 1 and Part 2 when administered with ketoconazole, fluvoxamine and/or carbamazepine. In addition: To evaluate the safety of pomalidomide in Part 1 and Part 2 when administered with ketoconazole, fluvoxamine and/or carbamazepine.

Timeline

Start: 2012-09-01
Primary completion: 2012-11-01
Completion: 2012-11-01

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carbamazepine	Small molecule	200 mg	Oral
Subject	Fluvoxamine	Unknown	50 mg	Oral
Subject	Ketoconazole	Small molecule	200 mg	Oral
Subject	Pomalidomide	Other / unclassified	4 mg	Oral

Indications

No indication recorded.

A Phase 1 Open-Label Study to Evaluate the Effect of CYP450 and P-gp Inhibition and Induction on the Pharmacokinetics of Pomalidomide (CC-4047) in Healthy Male Subjects

Summary

Timeline

Publications

Drugs

Indications