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Study of VX-770 and Rifampin in Healthy Male Subjects

Primary Purpose

Cystic Fibrosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

VX-770

Rifampin

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

VX-770

Rifampin

Arm Description

Outcomes

Primary Outcome Measures

VX 770 pharmacokinetic (PK) parameters

Secondary Outcome Measures

VX 770 metabolite PK parameters in plasma

Rifampin concentration at time zero (C0) and AUC at steady state (AUCtau) following the administration of multiple doses of rifampin

Safety as measured by adverse events, physical examinations, vital signs, electrocardiograms (ECGs), and clinically significant laboratory assessments

Full Information

NCT ID

NCT01018368

First Posted

November 19, 2009

Last Updated

May 6, 2010

Sponsor

Vertex Pharmaceuticals Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01018368

Brief Title

Study of VX-770 and Rifampin in Healthy Male Subjects

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 Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Vertex Pharmaceuticals Incorporated

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

VX-770

Arm Type

Experimental

Arm Title

Rifampin

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

VX-770

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Rifampin

Intervention Description

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

Primary Outcome Measure Information:

Title

VX 770 pharmacokinetic (PK) parameters

Time Frame

17 days

Secondary Outcome Measure Information:

Title

VX 770 metabolite PK parameters in plasma

Time Frame

17 days

Title

Rifampin concentration at time zero (C0) and AUC at steady state (AUCtau) following the administration of multiple doses of rifampin

Time Frame

17 days

Title

Safety as measured by adverse events, physical examinations, vital signs, electrocardiograms (ECGs), and clinically significant laboratory assessments

Time Frame

17 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

H. Frank Farmer, MD

Organizational Affiliation

Covance CRU, Inc.

Official's Role

Principal Investigator

Facility Information:

City

Daytona Beach

State/Province

Florida

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Study of VX-770 and Rifampin in Healthy Male Subjects

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