NCT01980329

CompletedPhase 1

Polymorphic Effects of Cytochrome P450 3A5 on Pharmacokineti...

Johns Hopkins University Source

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Other study identifiers

Sponsor study identifier

NA_00078492

Study Type

interventional

Actual enrollment (reported)

24

Locations

1 country

Sites

1

Timeline

Study Start

January 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2014

Actual (reported)

Study Completion

March 2014

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 24 participants
Study completion date: March 2014
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2013
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
November 4, 2013
Actual (reported)
First Posted
November 8, 2013
Actual (reported)
Primary Completion
March 2014
Actual (reported)
Study Completion
March 2014
Actual (reported)

Last Updated: April 6, 2015
Status Verified: April 2015
Last Update Submitted: April 2, 2015

Conditions

Cytochrome P450 CYP3A5 Enzyme Polymorphism Healthy Subjects Pharmacokinetics of Maraviroc

Keywords

CYP3A5maravirocpolymorphism

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

MaravirocDrug

Also known as: Selzentry

Maraviroc

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Healthy with no acute medical illness
Willing to provide written informed consent

Sponsors & Collaborators

Johns Hopkins University
Otherlead

Study Sites (1)

The Johns Hopkins University School of Medicine Division of Clinical Pharmacology

Baltimore, Maryland, 21210, United States

MeSH Terms

Interventions

Maraviroc

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

Namandje N Bumpus, Ph.D
Johns Hopkins University
PRINCIPAL INVESTIGATOR
Craig W Hendrix, MD
Johns Hopkins University
PRINCIPAL INVESTIGATOR

Enrollment

24 participants (actual enrollment reported by the registry).

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 2013

Date type not reported

This date has not been verified as actual or estimated.

NCT00703586

Study of the Antiviral and Immunological Effects of Intensification of Suppressive Antiretroviral Therapy With Maraviroc

Phase 1Completed

NCT02778204

Evaluating the Safety and Pharmacokinetics of Maraviroc in HIV-1-Exposed Infants at Risk of Acquiring HIV-1 Infection

Phase 1Completed

NCT00982878

The Maraviroc Central Nervous System (CNS) Study

Phase 1Completed

NCT02625207

THE EFFECT OF CYP3A5 GENOTYPE ON THE PHARMACOKINETICS OF MARAVIROC

Phase 1Completed

NCT00771823

Maraviroc 300 mg Twice Daily in HIV Negative Male Volunteers

Phase 1Completed

NCT02480894

A Open-label, Drug-Drug Interaction With Maraviroc (DDI)

Phase 1Completed

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

Contact the study team to confirm eligibility.

Primary Completion

March 2014

Actual (reported)

Study Completion

March 2014

Actual (reported)

Last Updated

April 6, 2015

Record last verified: 2015-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01980329
Data provider: ClinicalTrials.gov
Source updated: 2015-04-06
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:23:50 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Maraviroc

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations