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Completed

NCT Number: NCT01056874

Effect Of Maraviroc On The Pharmacokinetics Of Digoxin

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

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Key information

Conditions

Healthy Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digoxin

Drug

Oral Digoxin 0.25 mg single dose

Maraviroc

Drug

Oral Maraviroc 300 mg twice daily for 6 days

Other names: Selzentry, Celsentri

Primary outcomes

  1. To estimate the effect of multiple dose maraviroc on the pharmacokinetics of digoxin.

    Time frame: 21 days

Secondary outcomes

  1. To investigate the safety and tolerability of maraviroc and digoxin when co-administered.

    Time frame: 21 days

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 26, 2010
Registry last updated
Apr 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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