Back to results

Effect Of Maraviroc On The Pharmacokinetics Of Digoxin

Primary Purpose

Healthy, HIV Infections

Status

Completed

Phase

Phase 1

Locations

Singapore

Study Type

Interventional

Intervention

Digoxin

Maraviroc

About this trial

This is an interventional treatment trial for Healthy focused on measuring Maraviroc, Digoxin, P-glycoprotein, Pharmacokinetics, Drug Interaction, HIV

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Digoxin

Digoxin + Maraviroc

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01056874

First Posted

January 22, 2010

Last Updated

April 6, 2011

Sponsor

ViiV Healthcare

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01056874

Brief Title

Effect Of Maraviroc On The Pharmacokinetics Of Digoxin

Official Title

Open-Label, Fixed Sequence, Crossover Study To Estimate The Effect Of Multiple Dose Maraviroc On Single Dose Digoxin Pharmacokinetics In Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

ViiV Healthcare

Collaborators

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, HIV Infections

Keywords

Maraviroc, Digoxin, P-glycoprotein, Pharmacokinetics, Drug Interaction, HIV

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Digoxin

Arm Type

Active Comparator

Arm Title

Digoxin + Maraviroc

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Digoxin

Intervention Description

Oral Digoxin 0.25 mg single dose

Intervention Type

Drug

Intervention Name(s)

Digoxin

Intervention Description

Oral Digoxin 0.25 mg single dose on Day 5

Intervention Type

Drug

Intervention Name(s)

Maraviroc

Other Intervention Name(s)

Selzentry, Celsentri

Intervention Description

Oral Maraviroc 300 mg twice daily for 6 days

Primary Outcome Measure Information:

Title

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

Time Frame

21 days

Secondary Outcome Measure Information:

Title

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

Time Frame

21 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Total body weight >50 kg (110 lbs). Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Singapore

ZIP/Postal Code

188770

Country

Singapore

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4001097&StudyName=Effect%20Of%20Maraviroc%20On%20The%20Pharmacokinetics%20Of%20Digoxin

Description

To obtain contact information for a study center near you, click here.

Learn more about this trial

Effect Of Maraviroc On The Pharmacokinetics Of Digoxin

We'll reach out to this number within 24 hrs