Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363630
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2024-04-09
Brief Title:
A Study to Evaluate the Effect of Cytochrome P450 CYP 3A Inhibitor Itraconazole and Inducer Rifampin on the Drug Levels of Golcadomide BMS-986369 in Healthy Participants
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
A Phase 1 Open-label 2-part 2-period Fixed-sequence Crossover Study to Evaluate the Effect of Cytochrome P450 CYP 3A Inhibitor Itraconazole and Inducer Rifampin on the Pharmacokinetics of Golcadomide BMS-986369 in Healthy Participants
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the drug-drug interaction DDI potential of coadministration of itraconazole or rifampin on the single dose drug levels of golcadomide
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None