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Effect Of Maraviroc On The Pharmacokinetics Of Digoxin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01056874
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : April 7, 2011
Sponsor:
Collaborator:
Pfizer
Information provided by:
ViiV Healthcare

Tracking Information
First Submitted Date  ICMJE January 22, 2010
First Posted Date  ICMJE January 26, 2010
Last Update Posted Date April 7, 2011
Study Start Date  ICMJE March 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2010)
To estimate the effect of multiple dose maraviroc on the pharmacokinetics of digoxin. [ Time Frame: 21 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2010)
To investigate the safety and tolerability of maraviroc and digoxin when co-administered. [ Time Frame: 21 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect Of Maraviroc On The Pharmacokinetics Of Digoxin
Official Title  ICMJE Open-Label, Fixed Sequence, Crossover Study To Estimate The Effect Of Multiple Dose Maraviroc On Single Dose Digoxin Pharmacokinetics In Healthy Subjects
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Healthy
  • HIV Infections
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Digoxin
    Intervention: Drug: Digoxin
  • Experimental: Digoxin + Maraviroc
    Interventions:
    • Drug: Digoxin
    • Drug: Maraviroc
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2010)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01056874
Other Study ID Numbers  ICMJE A4001097
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE ViiV Healthcare
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account ViiV Healthcare
Verification Date April 2011

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