Effect Of Maraviroc On The Pharmacokinetics Of Digoxin
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ClinicalTrials.gov Identifier: NCT01056874 |
Recruitment Status
:
Completed
First Posted
: January 26, 2010
Last Update Posted
: April 7, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy HIV Infections | Drug: Digoxin Drug: Maraviroc | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
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 |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | April 2010 |
Actual Study Completion Date : | April 2010 |

Arm | Intervention/treatment |
---|---|
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
|
- To estimate the effect of multiple dose maraviroc on the pharmacokinetics of digoxin. [ Time Frame: 21 days ]
- To investigate the safety and tolerability of maraviroc and digoxin when co-administered. [ Time Frame: 21 days ]

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Ages Eligible for Study: | 21 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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
Singapore | |
Pfizer Investigational Site | |
Singapore, Singapore, 188770 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
ClinicalTrials.gov Identifier: | NCT01056874 History of Changes |
Other Study ID Numbers: |
A4001097 |
First Posted: | January 26, 2010 Key Record Dates |
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 |