Effect Of Maraviroc On The Pharmacokinetics Of Digoxin
Primary Purpose
Healthy, HIV Infections
Status
Completed
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
Digoxin
Digoxin
Maraviroc
Sponsored by
About this trial
This is an interventional treatment trial for Healthy focused on measuring Maraviroc, Digoxin, P-glycoprotein, Pharmacokinetics, Drug Interaction, HIV
Eligibility 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.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Digoxin
Digoxin + Maraviroc
Arm Description
Outcomes
Primary Outcome Measures
To estimate the effect of multiple dose maraviroc on the pharmacokinetics of digoxin.
Secondary Outcome Measures
To investigate the safety and tolerability of maraviroc and digoxin when co-administered.
Full Information
NCT ID
NCT01056874
First Posted
January 22, 2010
Last Updated
April 6, 2011
Sponsor
ViiV Healthcare
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT01056874
Brief Title
Effect Of Maraviroc On The Pharmacokinetics Of Digoxin
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 Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
ViiV Healthcare
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an open labelled study to estimate the effect of maraviroc on the pharmacokinetics of digoxin, a probe for p-glycoprotein.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, HIV Infections
Keywords
Maraviroc, Digoxin, P-glycoprotein, Pharmacokinetics, Drug Interaction, HIV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Digoxin
Arm Type
Active Comparator
Arm Title
Digoxin + Maraviroc
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Digoxin
Intervention Description
Oral Digoxin 0.25 mg single dose
Intervention Type
Drug
Intervention Name(s)
Digoxin
Intervention Description
Oral Digoxin 0.25 mg single dose on Day 5
Intervention Type
Drug
Intervention Name(s)
Maraviroc
Other Intervention Name(s)
Selzentry, Celsentri
Intervention Description
Oral Maraviroc 300 mg twice daily for 6 days
Primary Outcome Measure Information:
Title
To estimate the effect of multiple dose maraviroc on the pharmacokinetics of digoxin.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
To investigate the safety and tolerability of maraviroc and digoxin when co-administered.
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
188770
Country
Singapore
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4001097&StudyName=Effect%20Of%20Maraviroc%20On%20The%20Pharmacokinetics%20Of%20Digoxin
Description
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Learn more about this trial
Effect Of Maraviroc On The Pharmacokinetics Of Digoxin
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