NCT01888393

Study of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and Healthy Subjects

A Phase 1, Open Label Study to Assess the Pharmacokinetics and Safety of Multiple Doses of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the pharmacokinetics (PK) and safety of multiple doses of lumacaftor in combination with ivacaftor in subjects with moderate hepatic impairment.

Conditions

• Hepatic Impairment
• Healthy

Interventions

Type	Name	Description
DRUG	lumacaftor 200 mg q12h + ivacaftor 250 mg q12h

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2013-06-27
• Last updated: 2013-11-19

Locations

2 sites across 2 countries: Czechia, Slovakia