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

NCT01980329 | Completed Phase 1

• 1 other identifier: NA_00078492
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cytochrome P450 CYP3A5 Enzyme Polymorphism; Healthy Subjects; Pharmacokinetics of Maraviroc

Keywords

CYP3A5; maraviroc; polymorphism

Outcome Measures

Primary Outcomes (1)

• Area under the plasma concentration-time curve

  0-32 hour post dose administration

Secondary Outcomes (4)

• Clearance

  0-32 hr post dose administration

• Plasma peak concentration

  0-32 hr post dose administration

• Plasma half-life

  0-32 hr post dose administration

• Urinary metabolic ratio

  0-32 hr post dose administration

Study Arms (1)

Maraviroc

EXPERIMENTAL

single oral administration of 300 mg maraviroc

Drug: Maraviroc

Interventions

Maraviroc DRUG

Also known as: Selzentry

Maraviroc

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)
• subjects with homozygous CYP3A5 allele \*1 (wild type)
• subjects with 1 CYP3A5\*1 allele and 1 mutant allele
• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

The Johns Hopkins University School of Medicine Division of Clinical Pharmacology

Baltimore, Maryland, 21210, United States

Location

MeSH Terms

Interventions

Maraviroc

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Namandje N Bumpus, Ph.D

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Craig W Hendrix, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 8, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 6, 2015

Record last verified: 2015-04

Locations

US (1)