Ignite Creation Date:
2024-05-06 @ 3:56 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02411435
Status:
COMPLETED
Last Update Posted:
2016-01-06
First Post:
2015-04-02
Brief Title:
Effect of Rifampin RIF on the Pharmacokinetics PK of Oral Cabotegravir CAB in Healthy Subjects
Sponsor:
ViiV Healthcare
Organization:
ViiV Healthcare
Study Overview
Official Title:
Phase I Single-center Open Label Fixed-sequence Cross-over Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Oral Cabotegravir in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2016-01
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:
CAB is an integrase inhibitor that is currently in Phase 2 clinical trials for the treatment and prevention of human immunodeficiency virus-1 HIV-1 infection RIF a rifamycin used for treatment of tuberculosis common co-infection in HIV-infected subjects is a known inducer of uridine diphosphate UDP-glucuronosyltransferases UGTs and Cytochrome P450 3A4 CYP3A4 CAB is primarily metabolized via UGT1A1 and UGT1A9 thus a drug interaction between CAB and RIF is possible This study will be a phase I single-center open label fixed-sequence cross-over study to compare the single dose PK of CAB oral 30 milligrams mg when co-administered with RIF 600 mg once daily at steady-state to those of CAB oral 30 mg administered alone Fifteen subjects are planned to be enrolled to obtain 12 evaluable subjects for this study
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