Effect Of Maraviroc On The Pharmacokinetics Of Digoxin
- 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
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