NCT01707407View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

September 1, 2012

Primary Completion Date

November 1, 2012

Study Completion Date

November 1, 2012

Conditions
Pharmacology, ClinicalHealthy
Interventions
DRUG

Pomalidomide

4 mg pomalidomide capsule administered orally once in the morning

DRUG

Ketoconazole

200 mg Ketoconazole tablet administered orally twice a day on Days 1-7.

DRUG

Fluvoxamine

50 mg Fluvoxamine tablet administered orally twice a day on Days 1-7.

DRUG

Carbamazepine

"100 mg Carbamazepine tablet administered orally once in the evening on Day 1~100 mg Carbamazepine tablet administered orally twice daily on Days 2-3~200 mg Carbamazepine tablet administered orally twice daily on Days 4-11"

Trial Locations (1)

53704

Covance Research Unit, Inc, Madison

Sponsors

Lead Sponsor

Celgene
All Listed Sponsors
lead

Celgene

INDUSTRY

NCT01707407 - 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 | Biotech Hunter | Biotech Hunter