Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06170723
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2023-12-06
Brief Title:
A Study to Assess the Effects of Itraconazole Food and pH on the Drug Levels of BMS-986368 in Healthy Participants
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
A Phase 1 2-Part Open-Label Fixed-Sequence Study to Evaluate the Effects of Itraconazole Food and pH on the Single Dose Pharmacokinetics of BMS-986368 in Healthy Participants
Status:
COMPLETED
Status Verified Date:
2024-06
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:
This 2-part study will evaluate the effect of coadministration of a Cytochrome P450 family 3 subfamily A CYP3A inhibitor itraconazole Part 1 and a high-fathigh-calorie meal and a modified gastric pH Part 2 on the single dose drug levels of BMS-986368 in healthy participants
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