NCT01290211

Brief Summary

This is will be an open-label, fixed-sequence, multiple dose crossover study in 2 cohorts of 14 healthy male and/or female subjects, to estimate the effect of maraviroc on the pharmacokinetics of amprenavir and ritonavir and fosamprenavir/ritonavir on the pharmacokinetics of maraviroc.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_1 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

First Submitted

Initial submission to the registry

February 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 29, 2011

Status Verified

June 1, 2011

Enrollment Period

2 months

First QC Date

February 3, 2011

Last Update Submit

June 27, 2011

Conditions

Healthy

Keywords

maravirocfosamprenavirdrug interactionpharmacokineticsHIVAIDSCCR5protease inhibitor

Outcome Measures

Primary Outcomes (4)

  • Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ.

    Period 1, Day 5

  • Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ.

    Period 2, Day 20

  • Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ.

    Period 2, Day 10

  • Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ.

    Period 2, Day 20

Secondary Outcomes (5)

  • Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20.

    Period 1, Day 5

  • Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20.

    Period 2, Day 20

  • Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20.

    Period 2, Day 10

  • Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20.

    Period 2, Day 20

  • Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments.

    25 Days

Study Arms (2)

Cohort 1

EXPERIMENTAL

Twice daily regimen

Drug: MaravirocDrug: Fosamprenavir/ritonavirDrug: Maraviroc + Fosamprenavir/ritonavir

Cohort 2

EXPERIMENTAL

Once daily regimen

Drug: MaravirocDrug: Fosamprenavir/ritonavirDrug: Maraviroc + Fosamprenavir/ritonavir

Interventions

MaravirocDRUG

maraviroc 300 mg BID x 5 days

Also known as: Selzentry, Celsentri
Cohort 1
Fosamprenavir/ritonavirDRUG

fosamprenavir/ritonavir 700/100 mg BID x 10 days

Cohort 1
Maraviroc + Fosamprenavir/ritonavirDRUG

maraviroc 300 mg BID + fosamprenavir/ritonavir 700/100 mg BID x 10 days

Cohort 1

Eligibility Criteria

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

You may qualify if:

  • Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
  • Total body weight \>50 kg (110 lbs).

You may not qualify if:

  • History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
  • Positive result for HIV, Hepatitis B or Hepatitis C virus.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
  • Known hypersensitivity or history of allergy to sulfonamides.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Brussels, B-1070, Belgium

Location

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

MaravirocfosamprenavirRitonavir

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 3, 2011

First Posted

February 4, 2011

Study Start

April 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

June 29, 2011

Record last verified: 2011-06

Locations

BE(1)