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Effect Of Maraviroc On The Pharmacokinetics Of Digoxin

Information source: ViiV Healthcare
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy; HIV Infections

Intervention: Digoxin (Drug); Digoxin (Drug); Maraviroc (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: ViiV Healthcare

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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

Clinical Details

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

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

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

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

Eligibility

Minimum age: 21 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Locations and Contacts

Pfizer Investigational Site, Singapore 188770, Singapore
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: March 2010
Last updated: April 6, 2011

Page last updated: August 23, 2015

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