Study of VX-770 and Rifampin in Healthy Male Subjects

Vertex Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Cystic Fibrosis

Treatments

Drug: VX-770

Drug: Rifampin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01018368

VX09-770-009

Details and patient eligibility

About

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

Full 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.

Enrollment

24 estimated patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts 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