Study of VX-770 and Rifampin in Healthy Male Subjects

Cystic Fibrosis Clinical Trial

Official title:

An Open-Label Phase 1 Study to Examine the Effect of Multiple Doses of Rifampin on the Single-Dose Pharmacokinetics of VX 770 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018368
• Other study ID #: VX09-770-009
• Status: Completed
• Phase: Phase 1
• First received: November 19, 2009
• Last updated: May 6, 2010
• Start date: November 2009
• Est. completion date: March 2010

Study information

• Verified date: May 2010
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objectives of this study are to evaluate the effects of multiple doses of rifampin on the single-dose pharmacokinetics of VX 770.

Description:

This is a single-center, nonrandomized, open-label, 2-period, 1-sequence crossover study to investigate the safety, tolerability and pharmacokinetics of VX 770 when administered alone or with rifampin.

All enrolled subjects will receive the same treatments and undergo the same procedures. In Period 1, subjects will receive a single dose of VX 770 on Day 1. In Period 2, subjects will receive a daily dose of rifampin on Days 1 through 10 and a single dose of VX 770 on Day 6.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Subject must be male and between 18 and 55 years of age

• Subject must have a body mass index (BMI) from 18 to 30 kg/m2

Exclusion Criteria:

• History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject

• Subjects who have active tuberculosis, human immunodeficiency virus, hepatitis C, or active hepatitis B

Study Design

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

Related Conditions & MeSH terms

• Cystic Fibrosis

Intervention

Drug:
• VX-770
In Period 1, subjects will receive a single oral dose of VX-770 150 mg on Day 1. In Period 2, subjects will receive a single oral dose of VX-770 150 mg on Day 6.
• Rifampin
In Period 2, subjects will receive a daily oral dose of rifampin 600 mg on Days 1 through 10

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VX 770 pharmacokinetic (PK) parameters		17 days	No
Secondary	VX 770 metabolite PK parameters in plasma		17 days	No
Secondary	Rifampin concentration at time zero (C0) and AUC at steady state (AUCtau) following the administration of multiple doses of rifampin		17 days	No
Secondary	Safety as measured by adverse events, physical examinations, vital signs, electrocardiograms (ECGs), and clinically significant laboratory assessments		17 days	Yes