NCT01597895

Brief Summary

The purpose of this study is to determine the effect that telaprevir and boceprevir has on the pharmacokinetics of maraviroc.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jul 2012

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

May 10, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

September 19, 2012

Status Verified

September 1, 2012

Enrollment Period

1 month

First QC Date

May 10, 2012

Last Update Submit

September 18, 2012

Conditions

Healthy

Keywords

maravirocboceprevirtelaprevirdrug interactionpharmacokineticsHIV

Outcome Measures

Primary Outcomes (1)

  • Maraviroc plasma pharmacokinetic parameters: AUC12, Cmax, and C12h on Period 1, Day 5 and Periods 2 and 3, Day 10

    25 days

Secondary Outcomes (3)

  • Maraviroc plasma pharmacokinetic parameters: Tmax on Period 1, Day 5 and Periods 2 and 3, Day 10

    25 days

  • Boceprevir plasma pharmacokinetic parameters: AUC8, Cmax, C8h, and Tmax on Period 2, Day 10

    10 days

  • Telaprevir plasma pharmacokinetic parameters: AUC8, Cmax, C8h, and Tmax on Period 3, Day 10

    10 days

Study Arms (3)

Maraviroc

ACTIVE COMPARATOR
Drug: Maraviroc

Maraviroc + Boceprevir

EXPERIMENTAL
Drug: Maraviroc + Boceprevir

Maraviroc + Telaprevir

EXPERIMENTAL
Drug: Maraviroc + Telaprevir

Interventions

MaravirocDRUG

Maraviroc 150 mg BID x 5 days with food

Maraviroc
Maraviroc + BoceprevirDRUG

Maraviroc 150 mg BID + Boceprevir 800 mg TID x 10 days with food

Maraviroc + Boceprevir
Maraviroc + TelaprevirDRUG

Maraviroc 150 mg BID + Telaprevir 800 mg TID x 10 days with food

Maraviroc + Telaprevir

Eligibility Criteria

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

You may qualify if:

  • Healthy male and/or female subjects.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
  • Total body weight \>50 kg (110 lbs).

You may not qualify if:

  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
  • Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
  • Positive result for HIV-1, HIV-2, Hepatitis B serology (HbsAg, HbcAb) or anti hepatitis C virus serology (as determined by a multi antigen EIA).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Brussels, B-1070, Belgium

Location

Related Links

MeSH Terms

Interventions

MaravirocN-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamidetelaprevir

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2012

First Posted

May 14, 2012

Study Start

July 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

September 19, 2012

Record last verified: 2012-09

Locations

BE(1)