Clinical trial NCT00966602: Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2009-08-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Pharmacokinetic (PK) parameters of VX-770 and its metabolites in plasma in the presence and absence of VX-809
timeFrame: 70 days
measure: PK parameters of VX-809 in plasma in the presence and absence of VX-770
timeFrame: 70 days
Secondary outcomes:
measure: 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.
timeFrame: 70 days
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Medical Monitor
role: STUDY_DIRECTOR
References: