Status:
COMPLETED
Drug-Drug Interaction Study of VX-770 and VX-809 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 VX-809 and VX-770 alone and in combination in healthy subjects.
Detailed Description
This is a Phase 1, randomized, double-blind, placebo-controlled, multiple-dose study of orally administered VX-809 and VX-770 in healthy subjects. This study will evaluate safety and tolerability of V...
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 the contraception requirements
- Female subject must have a negative serum pregnancy test at screening and Day -1
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
- Participated in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 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 :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01216046
Start Date
October 1 2010
End Date
May 1 2011
Last Update
January 18 2012
Active Locations (1)
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1
PRA
Lenexa, Kansas, United States, 66219