Status:
COMPLETED
Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy Subjects
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 adul...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00966602
Start Date
September 1 2009
End Date
December 1 2009
Last Update
January 5 2010
Active Locations (1)
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1
Zuidlaren, Netherlands