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NCT01056874 Clinical Trial

Effect Of Maraviroc On The Pharmacokinetics Of Digoxin

Healthy Clinical Trial

Official title:
Open-Label, Fixed Sequence, Crossover Study To Estimate The Effect Of Multiple Dose Maraviroc On Single Dose Digoxin Pharmacokinetics In Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01056874
Other study ID # A4001097
Secondary ID
Status Completed
Phase Phase 1
First received January 22, 2010
Last updated April 6, 2011
Start date March 2010
Est. completion date April 2010

Study information
Verified date April 2011
Source ViiV Healthcare
Contact n/a
Is FDA regulated No
Health authority China: Centre for Pharmaceutical Administration Health Sciences Authority Singapore
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 55 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Digoxin
Oral Digoxin 0.25 mg single dose
• Digoxin
Oral Digoxin 0.25 mg single dose on Day 5
• Maraviroc
Oral Maraviroc 300 mg twice daily for 6 days

Locations
Country Name City State
Singapore Pfizer Investigational Site Singapore

Sponsors (2)
Lead Sponsor Collaborator
ViiV Healthcare Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome
Type Measure Description Time frame Safety issue
Primary To estimate the effect of multiple dose maraviroc on the pharmacokinetics of digoxin. 21 days No
Secondary To investigate the safety and tolerability of maraviroc and digoxin when co-administered. 21 days Yes
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