A Phase 2, Multicenter, Double Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects w...

Update Il y a 4 ans
Reference: EUCTR2011-003821-93

A Phase 2, Multicenter, Double Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation

Woman and Man

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Extract

-To evaluate the safety and tolerability of VX-661 monotherapy and VX-661/VX-770 cotherapy -To evaluate the effect of VX-661 monotherapy and VX-661/VX-770 cotherapy on CFTR function


Inclusion criteria

  • Cystic fibrosis