CFDB - Cystic Fibrosis DataBase

ongoing trials trial from www.clinicaltrials.gov

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 - Phase 2 - Completed

Study design (if review, criteria of inclusion for studies)

Interventional - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment

Participants

Cystic Fibrosis - 12 Years and older   (Child, Adult, Senior)

Interventions

Drug: VX-661|Drug: ivacaftor|Drug: VX-661 placebo|Drug: ivacaftor placebo

Outcome measures

Safety and tolerability of active drug vs placebo|Absolute change in sweat chloride|Change in sweat chloride|Change in percent predicted forced expiratory volume in 1 second|Change in forced expiratory volume in 1 second|Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain score|PK parameters [Cmax, Cmin, Cavg, area under the concentration versus time curve(AUC), tmax] of VX-661, ivacaftor, and their respective metabolites in plasma when VX-661 is administered alone and when the 2 drugs are administered together

Keywords: Adult; Aged; CFTR Modulators; Genetic Predisposition to Disease; pharmacological_intervention; placebo; VX-770; VX-661; ivacaftor; Aminophenols; tezacaftor; Symdeko; Symkevi;