NCT01056874

CompletedPhase 1

Effect Of Maraviroc On The Pharmacokinetics Of Digoxin

ViiV Healthcare Source

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Other study identifiers

Sponsor study identifier

A4001097

Study Type

interventional

Actual enrollment (reported)

12

Locations

1 country

Sites

1

Timeline

Study Start

March 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2010

Actual (reported)

Study Completion

April 2010

Actual (reported)

Brief Summary

This is an open labelled study to estimate the effect of maraviroc on the pharmacokinetics of digoxin, a probe for p-glycoprotein.

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): 12 participants
Study completion date: April 2010
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.

First Submitted
January 22, 2010
Actual (reported)
First Posted
January 26, 2010
Actual (reported)
Study Start
March 2010
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
April 2010
Actual (reported)
Study Completion
April 2010
Actual (reported)

Last Updated: April 7, 2011
Status Verified: April 2011
Last Update Submitted: April 6, 2011

Conditions

Healthy HIV Infections

Keywords

MaravirocDigoxinP-glycoproteinPharmacokineticsDrug InteractionHIV

Outcome Measures

Primary Outcomes (1)

To estimate the effect of multiple dose maraviroc on the pharmacokinetics of digoxin.
21 days

Secondary Outcomes (1)

To investigate the safety and tolerability of maraviroc and digoxin when co-administered.
21 days

Study Arms (2)

Digoxin

ACTIVE COMPARATOR

Drug: Digoxin

Digoxin + Maraviroc

EXPERIMENTAL

Drug: DigoxinDrug: Maraviroc

Interventions

DigoxinDrug

Oral Digoxin 0.25 mg single dose

Digoxin

DigoxinDrug

Oral Digoxin 0.25 mg single dose on Day 5

Digoxin + Maraviroc

Eligibility Criteria

Age21 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive.
Body Mass Index (BMI) of 17.5 to 25.5 kg/m2.

Sponsors & Collaborators

Pfizer
Industrycollaborator
ViiV Healthcare
Industrylead

Study Sites (1)

Pfizer Investigational Site

Singapore, 188770, Singapore

MeSH Terms

Conditions

HIV Infections

Interventions

DigoxinMaraviroc

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital Diseases

Study Officials

Pfizer CT.gov Call Center
Pfizer
STUDY DIRECTOR

Enrollment

12 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

January 22, 2010

First Posted

January 26, 2010

Study Start

March 2010

Date type not reported

This date has not been verified as actual or estimated.

NCT01276990

Safety and Pharmacokinetics of Multiple Rising Oral Doses of BI 224436 in Healthy Male Volunteers.

Phase 1Withdrawn

NCT02778204

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

Phase 1Completed

NCT00703586

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

Phase 1Completed

NCT01306175

Drug Interaction Study of Digoxin and BI 10773

Phase 1Completed

NCT01134965

to Evaluate Effect of Multi Doses Flibans 100 mg Film-c Tablets on Single Dose PK of Digoxin 0.5 mg, Healthy Volunteers

Phase 1Completed

NCT00496782

Multicenter Pilot Study To Define The Marker As An Alternate For Tropism Assay

Phase 1Terminated

MaravirocDrug

Oral Maraviroc 300 mg twice daily for 6 days

Also known as: Selzentry, Celsentri

Digoxin + Maraviroc

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

Total body weight \>50 kg (110 lbs).

You may not qualify if:

Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
Subjects with an estimated creatinine clearance (CLcr) \<80 ml/min.
Pregnant or nursing females.
Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication until completion of study.

Contact the study team to confirm eligibility.

Immunologic Deficiency Syndromes

Immune System Diseases

Intervention Hierarchy (Ancestors)

Digitalis GlycosidesCardenolidesCardiac GlycosidesCardanolidesSteroidsFused-Ring CompoundsPolycyclic CompoundsGlycosidesCarbohydratesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Primary Completion

April 2010

Actual (reported)

Study Completion

April 2010

Actual (reported)

Last Updated

April 7, 2011

Record last verified: 2011-04

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: NCT01056874
Data provider: ClinicalTrials.gov
Source updated: 2011-04-07
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:24 UTC

Locations

SG(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Digoxin

Digoxin + Maraviroc

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations