Effect Of Maraviroc On The Pharmacokinetics Of Digoxin

ViiV Healthcare12 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy HIV Infections

Interventions

DigoxinDRUG

Oral Digoxin 0.25 mg single dose

DigoxinDRUG

Oral Digoxin 0.25 mg single dose on Day 5

MaravirocDRUG

Oral Maraviroc 300 mg twice daily for 6 days

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

Singapore, Singapore

Outcomes

Primary Outcomes

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

Time frame: 21 days

Secondary Outcomes

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

Time frame: 21 days

Data from ClinicalTrials.gov

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