Polymorphic Effects of Cytochrome P450 3A5 on Pharmacokinetics of Maraviroc and Its Metabolites
Completed · Phase 1
Conditions studied: Cytochrome P450 CYP3A5 Enzyme Polymorphism, Healthy Subjects, Pharmacokinetics of Maraviroc
In brief
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
Key facts
- Study ID
- NCT01980329
- Run by
- Johns Hopkins University
- People needed
- 24
- Starts
- 2013-01-01
- Expected to finish
- 2014-03-01
- Last updated by the study team
- 2015-04-06
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The Johns Hopkins University School of Medicine Division of Clinical Pharmacology — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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