Healthy, HIV Infections
Conditions
Keywords
Maraviroc, Digoxin, P-glycoprotein, Pharmacokinetics, Drug Interaction, HIV
Brief summary
This is an open labelled study to estimate the effect of maraviroc on the pharmacokinetics of digoxin, a probe for p-glycoprotein.
Interventions
DRUGDigoxin
Oral Digoxin 0.25 mg single dose
DRUGMaraviroc
Oral Maraviroc 300 mg twice daily for 6 days
Sponsors
Pfizer
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate the effect of multiple dose maraviroc on the pharmacokinetics of digoxin. | 21 days |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the safety and tolerability of maraviroc and digoxin when co-administered. | 21 days |
Countries
Singapore
Outcome results
None listed