Study of VX-770 and Rifampin in Healthy Male Subjects

Sponsor

Vertex Pharmaceuticals Incorporated (Industry)

Overall Status

Completed

CT.gov ID

NCT01018368

Collaborator

(none)

Enrollment

Location

Arms

3.9

Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Drug: VX-770 Drug: Rifampin	Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Nov 1, 2009

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VX-770	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.
Experimental: Rifampin	Drug: Rifampin In Period 2, subjects will receive a daily oral dose of rifampin 600 mg on Days 1 through 10

Arm

Intervention/Treatment

Experimental: VX-770

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.

Experimental: Rifampin

Drug: Rifampin

In Period 2, subjects will receive a daily oral dose of rifampin 600 mg on Days 1 through 10

Outcome Measures

Primary Outcome Measures

VX 770 pharmacokinetic (PK) parameters [17 days]

Secondary Outcome Measures

VX 770 metabolite PK parameters in plasma [17 days]
Rifampin concentration at time zero (C0) and AUC at steady state (AUCtau) following the administration of multiple doses of rifampin [17 days]
Safety as measured by adverse events, physical examinations, vital signs, electrocardiograms (ECGs), and clinically significant laboratory assessments [17 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Daytona Beach	Florida	United States

Sponsors and Collaborators

Vertex Pharmaceuticals Incorporated

Investigators

Principal Investigator: H. Frank Farmer, MD, Covance CRU, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01018368

Other Study ID Numbers:

VX09-770-009

First Posted:

Nov 23, 2009

Last Update Posted:

May 10, 2010

Last Verified:

May 1, 2010

Additional relevant MeSH terms:

Cystic Fibrosis

Rifampin

Study Results

No Results Posted as of May 10, 2010