Effect Of Maraviroc On The Pharmacokinetics Of Digoxin

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01056874
First received: January 22, 2010
Last updated: April 6, 2011
Last verified: April 2011

January 22, 2010
April 6, 2011
March 2010
April 2010   (final data collection date for primary outcome measure)
To estimate the effect of multiple dose maraviroc on the pharmacokinetics of digoxin. [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01056874 on ClinicalTrials.gov Archive Site
To investigate the safety and tolerability of maraviroc and digoxin when co-administered. [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect Of Maraviroc On The Pharmacokinetics Of Digoxin
Open-Label, Fixed Sequence, Crossover Study To Estimate The Effect Of Multiple Dose Maraviroc On Single Dose Digoxin Pharmacokinetics In Healthy Subjects

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Healthy
  • HIV Infections
  • Drug: Digoxin
    Oral Digoxin 0.25 mg single dose
  • Drug: Digoxin
    Oral Digoxin 0.25 mg single dose on Day 5
  • Drug: Maraviroc
    Oral Maraviroc 300 mg twice daily for 6 days
    Other Name: Selzentry, Celsentri
  • Active Comparator: Digoxin
    Intervention: Drug: Digoxin
  • Experimental: Digoxin + Maraviroc
    Interventions:
    • Drug: Digoxin
    • Drug: Maraviroc
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
April 2010
April 2010   (final data collection date for primary outcome measure)

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.
Both
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01056874
A4001097
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ViiV Healthcare
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
ViiV Healthcare
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP