NCT01208285

Study of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects

A Phase 1 Non-Randomized, Open-Label Study to Assess the Safety and Pharmacokinetics of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the pharmacokinetics and safety of a single dose of VX-770 in subjects with moderate hepatic impairment.

Conditions

• In Development for Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	VX-770	150 mg oral tablet

Timeline

• Start date: 2010-09-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-09-23
• Last updated: 2011-01-12

Locations

3 sites across 2 countries: Czechia, Slovakia