Effect Of Maraviroc On The Pharmacokinetics Of Digoxin

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ViiV Healthcare
• Collaborator: Pfizer
• Treatments: Digoxin; Maraviroc

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.