NCT00666705

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4 healthy

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2008

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 4, 2009

Completed
Last Updated

January 25, 2013

Status Verified

January 1, 2013

Enrollment Period

29 days

First QC Date

April 23, 2008

Results QC Date

March 5, 2009

Last Update Submit

January 16, 2013

Conditions

Healthy

Keywords

maravirocraltegravirdrug interaction studyhealthy volunteers

Outcome Measures

Primary Outcomes (4)

  • Maraviroc Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)

    Effect of raltegravir on pharmacokinetics of maraviroc (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir).

    Days 11 and 14

  • Maraviroc Pharmacokinetic (PK) Parameter: Maximum Concentration (Cmax)

    Effect of raltegravir on pharmacokinetics of maraviroc (comparison of Cmax of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir). Cmax is the maximum plasma concentration.

    Days 11 and 14

  • Raltegravir Pharmacokinetics (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)

    Effect of maraviroc on pharmacokinetics of raltegravir (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus raltegravir administered alone (Reference)). Pharmacokinetics were assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir).

    Days 3 and 14

  • Raltegravir Pharmacokinetics (PK) Parameter: Maximum Concentration (Cmax)

    Effect of maraviroc on pharmacokinetics of raltegravir (comparison of Cmax of raltegravir co-administered with maraviroc (Test) versus raltegravir administered alone (Reference)). Pharmacokinetics assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir). Cmax is the maximum plasma concentration.

    Days 3 and 14

Other Outcomes (2)

  • Maraviroc Pharmacokinetic (PK) Parameter: 12-Hour Trough Concentration (C12)

    Days 11 and 14

  • Raltegravir Pharmacokinetics (PK) Parameter: 12-Hour Trough Concentration (C12)

    Days 3 and 14

Study Arms (3)

Maraviroc alone

EXPERIMENTAL
Drug: Maraviroc

Maraviroc + Raltegravir

EXPERIMENTAL
Drug: MaravirocDrug: Raltegravir

Raltegravir alone

EXPERIMENTAL
Drug: Raltegravir

Interventions

MaravirocDRUG

300 milligrams(mg) every 12 hours Days 6-11

Also known as: Selzentry, Celsentri
Maraviroc alone
RaltegravirDRUG

Days 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14)

Maraviroc + Raltegravir

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and/or female subjects between 18 and 55 years of age.

You may not qualify if:

  • Evidence or history of clinically significant disease or clinical findings at screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

MeSH Terms

Interventions

MaravirocRaltegravir Potassium

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolidinonesPyrrolidines

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.govCallCenter@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2008

First Posted

April 25, 2008

Study Start

February 1, 2008

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

January 25, 2013

Results First Posted

June 4, 2009

Record last verified: 2013-01

Locations

US(1)