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 Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
The Johns Hopkins University School of Medicine Division of Clinical Pharmacology
Baltimore, Maryland, United States
Area under the plasma concentration-time curve
Time frame: 0-32 hour post dose administration
Clearance
Time frame: 0-32 hr post dose administration
Plasma peak concentration
Time frame: 0-32 hr post dose administration
Plasma half-life
Time frame: 0-32 hr post dose administration
Urinary metabolic ratio
Time frame: 0-32 hr post dose administration
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