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drugset / Trial / NCT01888393

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

NCT01888393 ↗

Phase 1 Completed 23 enrolled Vertex Pharmaceuticals Incorporated
Non-randomizedParallel-groupOpen-label

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.

Timeline

Start
2013-06
Primary completion
2013-11
Completion
2013-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Ivacaftor Other / unclassified 250 mg —
Subject Lumacaftor Small molecule 200 mg —

Indications

No indication recorded.