Phase 1, QT/QTC Interval Study in Healthy Subjects

NCT01910415 ↗

Phase 1 Completed 200 enrolled Vertex Pharmaceuticals Incorporated

RandomizedFactorialDouble-blindTreatment

Summary

This study is designed to evaluate the effect of multiple doses of lumacaftor in combination with ivacaftor on cardiac repolarization, as detected by QT/QTc interval corrected for heart rate in healthy subjects.

Timeline

Start: 2013-06
Primary completion: 2014-03
Completion: 2014-03

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ivacaftor	Other / unclassified	450 mg	—
Subject	Lumacaftor	Small molecule	600 mg	—
Subject	Lumacaftor	Small molecule	1000 mg	—
Subject	Lumacaftor	Small molecule	1200 mg	—
Subject	Moxifloxacin	Small molecule	400 mg	—

Phase 1, QT/QTC Interval Study in Healthy Subjects

Summary

Timeline

Drugs

Indications