drugset
drugset / Trial / NCT01531673

Study of VX-661 Alone and in Combination With Ivacaftor in Subjects Homozygous or Heterozygous to the F508del-Cystic Fibrosis Transmembrane Conductance Regulator(CFTR) Mutation

NCT01531673 ↗

Phase 2 Completed 194 enrolled Vertex Pharmaceuticals Incorporated
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) effects of VX-661 alone and when coadministered with ivacaftor in participants with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del-CFTR mutation.

Timeline

Start
2012-02
Primary completion
2014-03
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Ivacaftor Other / unclassified 50 mg Oral
Subject Ivacaftor Other / unclassified 150 mg Oral
Subject tezacaftor Other / unclassified 10 mg Oral
Subject tezacaftor Other / unclassified 30 mg Oral
Subject tezacaftor Other / unclassified 50 mg Oral
Subject tezacaftor Other / unclassified 100 mg Oral
Subject tezacaftor Other / unclassified 150 mg Oral

Indications

cystic fibrosis