Effect Of Maraviroc On The Pharmacokinetics Of Digoxin

ViiV Healthcare

Status and phase: Completed; Phase 1

Conditions: Healthy; HIV Infections

Treatments: Drug: Digoxin; Drug: Maraviroc

Study type: Interventional

Funder types: Industry

Identifiers

NCT01056874

A4001097

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Digoxin

Active Comparator group

Treatment:

Drug: Digoxin

Drug: Digoxin

Digoxin + Maraviroc

Experimental group

Treatment:

Drug: Maraviroc

Drug: Digoxin

Drug: Digoxin