NCT02168205

Food Effect and CYP1A2 Induction Study in Healthy Subjects

Hase I Open-Label Two-Part Study To Evaluate The Effect Of Food and Of CYP1A2 Induction On Pomalidomide (CC-4047) Pharmacokinetics in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the effect of food and smoking on healthy older subjects taking pomalidomide.

Detailed description

This study will be conducted in two parts. Parts 1 and 2 may be conducted in parallel and subjects are only allowed to participate in one part. In Part 1, subjects will be randomly assigned to receive a single oral dose of 4 mg pomalidomide on Day 1 under fed (standard high fat breakfast) or fasted conditions. After a washout period of at least 3 and no more than 7 days, subjects will receive a single oral dose of 4 mg pomalidomide under the opposite condition to what they received in the first period. In Part 2, healthy male smoker subjects must smoke approximately 20 cigarettes per day for a total of 10 days. Non-smokers will neither smoke nor be in the presence of smokers. All subjects will receive orally a 200-mg caffeine capsule on Day 6, and on Day 8, subjects will receive a single oral dose of 4 mg pomalidomide. For both Parts 1 and 2, serial blood samples will be collected for determination of plasma pomalidomide concentrations.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Pomalidomide	Capsules
OTHER	Caffeine	Capsules
OTHER	Tobacco	Cigarettes

Timeline

• Start date: 2014-05-30
• Primary completion: 2014-09-19
• Completion: 2014-09-19
• First posted: 2014-06-20
• Last updated: 2018-11-15

Locations

1 site across 1 country: United States