Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT00966602|
Recruitment Status : Completed
First Posted : August 27, 2009
Last Update Posted : January 5, 2010
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: VX-809 Drug: VX-770 Drug: VX-809 & VX-770 Drug: Placebo||Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy Subjects|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
|Experimental: Treatment Period 1||
VX-809 capsule, once daily for 14 daysDrug: Placebo
|Experimental: Treatment Period 2||
VX-770 tablet, once every 12 hours for 14 daysDrug: 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 daysDrug: Placebo
- Pharmacokinetic (PK) parameters of VX-770 and its metabolites in plasma in the presence and absence of VX-809 [ Time Frame: 70 days ]
- PK parameters of VX-809 in plasma in the presence and absence of VX-770 [ Time Frame: 70 days ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966602
|Study Director:||Medical Monitor||Vertex Pharmaceuticals Incorporated|