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Lenexa, Kansas 66219


Purpose:

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.


Study summary:

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 VX-809 and VX-770 alone and in combination. Subjects will be randomized to receive study drug or placebo during three 14-day treatment periods separated by 14-day washout periods. In Treatment Period 1, subjects randomized to study drug will receive VX-809 every 24 hours. In Treatment Period 2, subjects randomized to study drug will receive VX-770 every 12 hours. In Treatment Period 3, subjects will receive VX-809 every 24 hours and VX-770 every 12 hours. Subjects randomized to placebo will receive placebo during all treatment periods. Enrollment is planned at 1 clinical site (Lenexa, Kansas). Up to 72 subjects will be enrolled. The study will be separated into 3 dose escalation cohorts. Cohort 1 and Cohort 2 will enroll 24 subjects. Cohort 3 is optional and may be conducted after a review of safety and pharmacokinetic data by Vertex.


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


NCT ID:

NCT01216046


Primary Contact:

Study Director
Laurent Vernillet, PharmD, PhD, FCP
Vertex Pharmaceuticals Incorporated


Backup Contact:

N/A


Location Contact:

Lenexa, Kansas 66219
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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