THE EFFECT OF CYP3A5 GENOTYPE ON THE PHARMACOKINETICS OF MARAVIROC

Phase 1 Completed 47 enrolled ViiV Healthcare Pfizer · collab

Non-randomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start: 2015-11-06
Primary completion: 2016-03-26
Completion: 2016-03-26

Publications

Vourvahis M, McFadyen L, Nepal S, Valluri SR, Fang A, Fate GD, Wood LS, Marshall JC, Chan PLS, Nedderman A, Haynes J, Savage ME, Clark A, Smith KY, Heera J. No Clinical Impact of CYP3A5 Gene Polymorphisms on the Pharmacokinetics and/or Efficacy of Maraviroc in Healthy Volunteers and HIV-1-Infected Subjects. J Clin Pharmacol. 2019 Jan;59(1):139-152. doi: 10.1002/jcph.1306. Epub 2018 Sep 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Darunavir/cobicistat	Unknown	150 mg	—
Subject	Darunavir/cobicistat	Unknown	800 mg	—
Subject	Maraviroc	Other / unclassified	150 mg	—
Subject	Maraviroc	Other / unclassified	300 mg	—

Indications

No indication recorded.