Expired Study
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New Haven, Connecticut 06511


Purpose:

An open label study to evaluate an interaction between maraviroc and raltegravir in healthy subjects.


Study summary:

Drug interaction study


Criteria:

Inclusion Criteria: - Healthy male and/or female subjects between 18 and 55 years of age. Exclusion Criteria: - Evidence or history of clinically significant disease or clinical findings at screening


Study is Available At:


Original ID:

A4001082


NCT ID:

NCT00666705


Secondary ID:


Study Acronym:


Brief Title:

A Study To Evaluate An Interaction Between Maraviroc And Raltegravir In Healthy Subjects


Official Title:

An Open Label Phase 4 Study To Evaluate An Interaction Between Maraviroc And Raltegravir In Healthy Subjects


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pfizer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

18


Enrollment Type:

Actual


Overall Contact Information

Official Name:Pfizer CT.gov Call Center
Study Director
Pfizer

Study Dates

Start Date:February 2008
Completion Date:March 2008
Completion Type:Actual
Primary Completion Date:March 2008
Primary Completion Type:Actual
Verification Date:June 2009
Last Changed Date:June 4, 2009
First Received Date:April 23, 2008
First Results Date:March 5, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure:Raltegravir Pharmacokinetics (PK) Parameter: Maximum Concentration (Cmax)
Time Frame:Days 3 and 14
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Raltegravir Pharmacokinetics (PK) Parameter: Area Under the Plasma Concentration-Time Profile Over the Dosing Interval (AUCτ)
Time Frame:Days 3 and 14
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Maraviroc Pharmacokinetic (PK) Parameter: Maximum Concentration (Cmax)
Time Frame:Days 11 and 14
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Maraviroc Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-Time Profile Over the Dosing Interval (AUCτ)
Time Frame:Days 11 and 14
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Maraviroc
Description:300 milligrams(mg) every 12 hours Days 6-11
Arm Name:Maraviroc alone
Other Name:Selzentry, Celsentri
Intervention Type:Drug
Name:Maraviroc
Description:Days 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14)
Arm Name:Maraviroc + Raltegravir
Intervention Type:Drug
Name:Raltegravir
Description:Days 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14)
Arm Name:Maraviroc + Raltegravir
Intervention Type:Drug
Name:Raltegravir
Description:400 milligrams(mg) every 12 hours Days 1-3 Followed by washout Days 4-5
Arm Name:Raltegravir alone

Study Arms

Study Arm Type:Experimental
Arm Name:Maraviroc alone
Study Arm Type:Experimental
Arm Name:Maraviroc + Raltegravir
Study Arm Type:Experimental
Arm Name:Raltegravir alone

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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