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

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Maraviroc

Criteria

Inclusion Criteria:

• Healthy with no acute medical illness

• Willing to provide written informed consent

• Age 18-65 years

• Negative serum pregnancy test (females only) at screening and a negative urine pregnancy test (females only) on day of dosing

• HIV seronegative at screening, as determined by any licensed ELISA

• At screening, no evidence of hepatic or renal impairment (LFT's < 1.5 Upper Limit of Normal (ULN), creatinine clearance > than 60 ml/min, total bilirubin below ULN, AST and ALT below 1.5 ULN)

• 8 subjects with homozygous CYP3A5 allele *1 (wild type)

• 8 subjects with 1 CYP3A5*1 allele and 1 mutant allele

• 8 subjects with CYP3A5 allele other than *1

Exclusion Criteria:

• Concomitant medication (prescription or over-the-counter) or herbal supplements for which there is a known risk of pharmacokinetic or pharmacodynamic drug interactions, including those that inhibit CYP3A4 as listed on the P450 Drug Interaction Table (http://medicine.iupui.edu/clinpharm/ddis/table.aspx)

• History of postural hypotension or cardiovascular disease

• Active medical or psychological condition that, in the opinion of the investigator, might put the volunteer at undue risk or interfere with the participation of the study