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

A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Drug: Placebo; Drug: VX-809; Drug: VX-770; Drug: VX-809 & VX-770

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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Zuidlaren, Netherlands

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Period 1	Drug: Placebo; Matching Placebo; Drug: VX-809; VX-809 capsule, once daily for 14 days
Experimental: Treatment Period 2	Drug: Placebo; Matching Placebo; Drug: VX-770; VX-770 tablet, once every 12 hours for 14 days
Experimental: Treatment Period 3	Drug: Placebo; Matching Placebo; Drug: VX-809 & VX-770; VX-809 capsule, once daily, and VX-770 tablets, once every 12 hours, for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic (PK) parameters of VX-770 and its metabolites in plasma in the presence and absence of VX-809	70 days
PK parameters of VX-809 in plasma in the presence and absence of VX-770	70 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	70 days

Collaborators and Investigators

• Sponsor: Vertex Pharmaceuticals Incorporated

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: August 25, 2009
• First Submitted That Met QC Criteria: August 25, 2009
• First Posted (Estimate): August 27, 2009

Study Record Updates

• Last Update Posted (Estimate): January 5, 2010
• Last Update Submitted That Met QC Criteria: January 2, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Cystic Fibrosis; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Chloride Channel Agonists; Ivacaftor
• Other Study ID Numbers: VX08-809-005