Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT02168205
Status:
COMPLETED
Last Update Posted:
2018-11-15
First Post:
2014-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Food Effect and CYP1A2 Induction Study in Healthy Subjects
Sponsor:
Celgene
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03723096
Has Expanded Access, NCT# Status:
NO_LONGER_AVAILABLE
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: