Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00966602
First received: August 25, 2009
Last updated: January 2, 2010
Last verified: January 2010
  Purpose

The purpose of this study is to assess the pharmacokinetics and safety of co-administration of VX-770 and VX-809 in healthy adults.


Condition Intervention Phase
Cystic Fibrosis
Drug: VX-809
Drug: VX-770
Drug: VX-809 & VX-770
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • Pharmacokinetic (PK) parameters of VX-770 and its metabolites in plasma in the presence and absence of VX-809 [ Time Frame: 70 days ] [ Designated as safety issue: No ]
  • PK parameters of VX-809 in plasma in the presence and absence of VX-770 [ Time Frame: 70 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety as measured by adverse events, physical examination, and clinically significant changes in laboratory values (hematology, chemistry, coagulation, and urinalysis), electrocardiograms (ECGs), and vital signs. [ Time Frame: 70 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: September 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Period 1 Drug: VX-809
VX-809 capsule, once daily for 14 days
Drug: Placebo
Matching Placebo
Experimental: Treatment Period 2 Drug: VX-770
VX-770 tablet, once every 12 hours for 14 days
Drug: Placebo
Matching Placebo
Experimental: Treatment Period 3 Drug: VX-809 & VX-770
VX-809 capsule, once daily, and VX-770 tablets, once every 12 hours, for 14 days
Drug: Placebo
Matching Placebo

Detailed Description:

Cystic fibrosis (CF) is an inherited disease resulting from defects to a gene known as the cystic fibrosis transmembrane conductance regulator (CFTR). CF affects approximately 70,000 children and adults worldwide (30,000 in the United States) and is the most common fatal genetic disease in persons of European descent. Despite progress in the treatment of CF with antibiotics and mucolytics, the predicted median age of survival for a person with CF is in the mid-30s. Though the disease affects multiple organs, most morbidity and mortality is caused by progressive loss of lung function.

This is a Phase 1, randomized, double-blind, placebo-controlled, multiple-dose study of orally administered VX-809 and VX-770 in healthy subjects. The study will evaluate safety and tolerability of co-administration of VX-809 and VX-770 in healthy volunteers.

Enrollment is planned for 24 subjects at 1 clinical site. Subjects will be randomized to receive study drug or placebo during three 14-day treatment periods separated by 14-day washout periods. In Treatment Period 1, subjects randomized to study drug will receive VX-809 every 24 hours. In Treatment Period 2, subjects randomized to study drug will receive VX-770 every 12 hours. In Treatment Period 3, subjects randomized to study drug will receive VX-809 every 24 hours and VX-770 every 12 hours. Subjects randomized to placebo will receive placebo during all treatment periods.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female subject between 18 and 55 years of age, inclusive
  • Body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive
  • Subjects of child-bearing potential and who are sexually active must meet contraception requirements
  • Female subject must have a negative serum pregnancy test at screening, Day -1, and throughout the study

Exclusion Criteria:

  • History of any illness 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. This may include but is not limited to a significant history of cardiovascular, central nervous system, hepatobiliary or renal disease, or a history of mental illness
  • Participated in a clinical study involving administration of either an investigational or a marketed drug within 60 days or 7 terminal half-lives (whichever is longer) before the Screening visit
  • Subject who has received VX-770 or VX-809 in a previous clinical study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966602

Locations
Netherlands
Zuidlaren, Netherlands
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Investigators
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
  More Information

No publications provided

Responsible Party: Medical Monitor, Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00966602     History of Changes
Other Study ID Numbers: VX08-809-005
Study First Received: August 25, 2009
Last Updated: January 2, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 18, 2014