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Effect Of Maraviroc On The Pharmacokinetics Of Digoxin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01056874
First Posted: January 26, 2010
Last Update Posted: April 7, 2011
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.
Collaborator:
Pfizer
Information provided by:
ViiV Healthcare
  Purpose
This is an open labelled study to estimate the effect of maraviroc on the pharmacokinetics of digoxin, a probe for p-glycoprotein.

Condition Intervention Phase
Healthy HIV Infections Drug: Digoxin Drug: Maraviroc Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Fixed Sequence, Crossover Study To Estimate The Effect Of Multiple Dose Maraviroc On Single Dose Digoxin Pharmacokinetics In Healthy Subjects

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • To estimate the effect of multiple dose maraviroc on the pharmacokinetics of digoxin. [ Time Frame: 21 days ]

Secondary Outcome Measures:
  • To investigate the safety and tolerability of maraviroc and digoxin when co-administered. [ Time Frame: 21 days ]

Enrollment: 12
Study Start Date: March 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Digoxin Drug: Digoxin
Oral Digoxin 0.25 mg single dose
Experimental: Digoxin + Maraviroc 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01056874


Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01056874     History of Changes
Other Study ID Numbers: A4001097
First Submitted: January 22, 2010
First Posted: January 26, 2010
Last Update Posted: April 7, 2011
Last Verified: April 2011

Keywords provided by ViiV Healthcare:
Maraviroc
Digoxin
P-glycoprotein
Pharmacokinetics
Drug Interaction
HIV

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Maraviroc
Digoxin
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Protective Agents
Physiological Effects of Drugs