THE EFFECT OF CYP3A5 GENOTYPE ON THE PHARMACOKINETICS OF MARAVIROC

• Status: Completed
• Trial end date: 2016-03-26
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ViiV Healthcare
• Collaborator: Pfizer
• Treatments: Cobicistat; Darunavir; Maraviroc

Criteria

Inclusion Criteria:

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)

• Healthy female subjects and/or male subjects of African-American/Black or Caucasian race

Exclusion Criteria:

• History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males

• Treatment with an investigational drug within 30 days

• Screening supine blood pressure <90 or >/=140 mm Hg (systolic) or <60 or >/= 90 mm Hg (diastolic), following at least 5 minutes of supine rest

• Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.

• Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day

• Subjects who have a CYP3A4*22 allele and/or have a SLCO1B1 *5 or *15 allele