NCT01216046

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

A Phase 1, Randomized, Double-Blind, Placebo Controlled, Multiple-Dose, Dose-Escalation, Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	VX-809	capsule, taken once daily
DRUG	VX-770	tablet, taken once every 12 hours
DRUG	VX-809 placebo	capsule, taken once daily
DRUG	VX-770 placebo	tablet, taken once every 12 hours

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2010-10-07
• Last updated: 2012-01-18

Locations

1 site across 1 country: United States