At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Open-label, Parallel-group Study To Assess The Effect Of Cyp3a5 Genotype On The Pharmacokinetics Of Maraviroc And Cyp3a5-derived Metabolites With And Without Darunavir/Cobicistat In African-american And Caucasian Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Maraviroc (Part 1), Maraviroc (Part 2), and 1 other intervention for Healthy Subjects. Completed, enrolled 47 participants across 1 site.
Detailed Summary
This will be an open-label, parallel group, multiple dose study in approximately 48 healthy male or female subjects of African American and Caucasian self-reported race, to assess the effect of CYP3A5 genotype on the PK of MVC and CYP3A5-derived metabolites. Maraviroc and CYP3A5-derived metabolite PK will also be compared between African-Americans and Caucasians in subjects carrying two copies of the dysfunctional CYP3A5 alleles (\*3, \*6, and/or \*7).
Study Details
Timeline
Interventions
300 mg twice daily x 5 days
150 mg once daily x 10 days
800/150 mg once daily x 10 days