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Study of VX-770 and Rifampin in Healthy Male Subjects

This study has been completed.
Information provided by:
Vertex Pharmaceuticals Incorporated Identifier:
First received: November 19, 2009
Last updated: May 6, 2010
Last verified: May 2010
The objectives of this study are to evaluate the effects of multiple doses of rifampin on the single-dose pharmacokinetics of VX 770.

Condition Intervention Phase
Cystic Fibrosis Drug: VX-770 Drug: Rifampin Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • VX 770 pharmacokinetic (PK) parameters [ Time Frame: 17 days ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: November 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
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
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Please refer to this study by its identifier: NCT01018368

United States, Florida
Daytona Beach, Florida, United States
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Principal Investigator: H. Frank Farmer, MD Covance CRU, Inc.
  More Information

Responsible Party: Medical Monitor, Vertex Pharmaceutical Incorporated Identifier: NCT01018368     History of Changes
Other Study ID Numbers: VX09-770-009
Study First Received: November 19, 2009
Last Updated: May 6, 2010

Additional relevant MeSH terms:
Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers processed this record on August 17, 2017