drugset / Trial / NCT01768663

A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult Subjects

NCT01768663

Phase 1 Completed 80 enrolled Vertex Pharmaceuticals Incorporated
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to examine the drug-drug interaction effects of ciprofloxacin, itraconazole, and rifampin on the pharmacokinetics of lumacaftor in combination with ivacaftor as well as to evaluate the potential effects of lumacaftor in combination with ivacaftor on lung function.

Timeline

Start
2013-01
Primary completion
2013-09
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Ciprofloxacin Small molecule 750 mg
Subject Itraconazole Small molecule 200 mg
Subject Ivacaftor Other / unclassified 250 mg
Subject Lumacaftor Small molecule 200 mg
Subject Rifampin Small molecule 600 mg

Indications