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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• 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 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