Estimate the Effect of Telaprevir and Boceprevir on Maraviroc Pharmacokinetics in Healthy Subjects

Healthy Clinical Trial

Official title:

Open-Label, Randomized, Fixed-Sequence, Crossover Study to Estimate the Effect of Telaprevir and Boceprevir on Maraviroc Pharmacokinetics in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01597895
• Other study ID #: A4001108
• Status: Completed
• Phase: Phase 1
• First received: May 10, 2012
• Last updated: September 18, 2012
• Start date: July 2012
• Est. completion date: August 2012

Study information

• Verified date: September 2012
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Maraviroc
Maraviroc 150 mg BID x 5 days with food
• Maraviroc + Boceprevir
Maraviroc 150 mg BID + Boceprevir 800 mg TID x 10 days with food
• Maraviroc + Telaprevir
Maraviroc 150 mg BID + Telaprevir 800 mg TID x 10 days with food

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maraviroc plasma pharmacokinetic parameters: AUC12, Cmax, and C12h on Period 1, Day 5 and Periods 2 and 3, Day 10		25 days	No
Secondary	Maraviroc plasma pharmacokinetic parameters: Tmax on Period 1, Day 5 and Periods 2 and 3, Day 10		25 days	No
Secondary	Boceprevir plasma pharmacokinetic parameters: AUC8, Cmax, C8h, and Tmax on Period 2, Day 10		10 days	No
Secondary	Telaprevir plasma pharmacokinetic parameters: AUC8, Cmax, C8h, and Tmax on Period 3, Day 10		10 days	No

External Links

•   To obtain contact information for a study center near you, click here.