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

Completed · Phase 1 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT01216046

Run by

Vertex Pharmaceuticals Incorporated

People needed

48

Starts

2010-10-01

Expected to finish

2011-05-01

Last updated by the study team

2012-01-18

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• PRA — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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