Study of VX-770 and Rifampin in Healthy Male Subjects

Vertex Pharmaceuticals Incorporated24 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

VX-770DRUG

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.

RifampinDRUG

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Daytona Beach, Florida, United States

Outcomes

Primary Outcomes

VX 770 pharmacokinetic (PK) parameters

Time frame: 17 days

Secondary Outcomes

VX 770 metabolite PK parameters in plasma

Time frame: 17 days

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

Time frame: 17 days

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

Time frame: 17 days

Data from ClinicalTrials.gov

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