Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543043
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-03
Brief Title:
A Study to Evaluate the Effects of Phenytoin and Itraconazole on Sonrotoclax BGB-11417 in Healthy Volunteers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-Label Parallel Group Study Designed to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of Sonrotoclax BGB-11417 in Healthy Subjects
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-center open-label parallel group study designed to investigate the effect of CYP3A induction and inhibition following multiple doses of phenytoin Part A and itraconazole Part B respectively on the pharmacokinetics of sonrotoclax in healthy volunteers
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None