Ignite Creation Date:
2024-07-17 @ 11:17 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493409
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-25
Brief Title:
A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
A Phase I Two-part Single-center Open-label Drug-drug Interaction Study to Assess the Effect of Voriconazole Part 1 and Quinidine Part 2 on the Pharmacokinetics of a Single Dose of Repotrectinib BMS-986472 in Healthy Participants
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT05926232
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effects of coadministration of voriconazole or quinidine on the pharmacokinetics PK of repotrectinib in healthy male and female individual not of childbearing potential INOCBP 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