Polymorphic Effects of Cytochrome P450 3A5 on Pharmacokinetics of Maraviroc and Its Metabolites

2015-04-15 11:08:22 | BioPortfolio


The purpose of this study is to evaluate the influence of genetic polymorphism of cytochrome P450 3A5 on pharmacokinetics of maraviroc and its oxidative metabolites


This study aims to evaluate the effects of CYP3A5 genotype on pharmacokinetics of maraviroc and its oxidative metabolites. A single oral dose of 300 mg maraviroc will be given to 24 eligible healthy individuals who will be screened and determined to have specific CYP3A5 genotype - 8 homozygous wild type (2 CYP3A5*1 alleles), 8 heterozygous (1 CYP3A5*1 allele and 1 mutant allele), and 8 without wild type genotype (2 mutant alleles). Blood samples will be drawn and urine samples will be collected immediately before and during a 32-hr period following the dose. The concentrations of maraviroc and its oxidative metabolites from the blood and urine samples will be measured and the pharmacokinetics of maraviroc and its metabolites will be compared among the three groups with different CYP3A5 polymorphic status.


Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Cytochrome P450 CYP3A5 Enzyme Polymorphism




The Johns Hopkins University School of Medicine Division of Clinical Pharmacology
United States




Johns Hopkins University

Results (where available)

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Published on BioPortfolio: 2015-04-15T11:08:22-0400

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Medical and Biotech [MESH] Definitions

A cytochrome P450 enzyme family whose members localize to the INNER MITOCHONDRIAL MEMBRANE where they function in the biosynthesis of STEROIDS.

A cytochrome P450 enzyme family whose members function in VITAMIN D metabolism and the biosynthesis of BILE ACIDS.

A cytochrome P450 enzyme family that functions in the biosynthesis of STEROIDS and includes STEROID 17-ALPHA-HYDROXYLASE.

A cytochrome P450 enzyme family that includes members which function in the metabolism of STEROIDS; COUMARINS; and NICOTINE.

A cytochrome P450 enzyme family that includes members with critical functions in the metabolism of drugs and SEX HORMONES.

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