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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Treatments: Ivacaftor

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 the contraception requirements

• Female subject must have a negative serum pregnancy test at screening and Day -1

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

• 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