THE EFFECT OF CYP3A5 GENOTYPE ON THE PHARMACOKINETICS OF MARAVIROC

Completed · Phase 1

Conditions studied: Healthy Subjects

In brief

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).

Key facts

Study ID

NCT02625207

Run by

ViiV Healthcare

People needed

47

Starts

2015-11-06

Expected to finish

2016-03-26

Last updated by the study team

2017-04-17

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pfizer New Haven Clinical Research Unit — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.