Effect Of Maraviroc On The Pharmacokinetics Of Digoxin
This study has been completed.
Sponsor:
ViiV Healthcare
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
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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 Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To investigate the safety and tolerability of maraviroc and digoxin when co-administered. [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
| 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| Ages Eligible for Study: | 21 Years to 55 Years (Adult) |
| Genders Eligible for Study: | Both |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01056874
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | January 22, 2010 |
| Last Updated: | April 6, 2011 |
| Health Authority: | China: Centre for Pharmaceutical Administration Health Sciences Authority Singapore |
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 |
ClinicalTrials.gov processed this record on September 23, 2016