Effect Of Maraviroc On The Pharmacokinetics Of Digoxin

Phase 1

Completed

• Conditions: Healthy; HIV Infections
• Interventions: Drug: Digoxin; Drug: Maraviroc

• Registration Number: NCT01056874
• Lead Sponsor: ViiV Healthcare

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-22
• Study First Submitted QC: 2010-01-22
• Study First Posted: 2010-01-26
• Study Start: 2010-03
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-06
• Last Update Posted: 2011-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Digoxin	Digoxin	-
Digoxin + Maraviroc	Digoxin	-
Digoxin + Maraviroc	Maraviroc	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore