Cystic fibrosis
Conditions
Brief summary
Safety and tolerability, based on the assessment of adverse events (AEs), laboratory test results, standard 12 lead ECGs, and vital signs, Absolute change in sweat chloride (SwCl) concentrations from baseline through Day 28
Detailed description
PK parameters of VX 828, TEZ, D IVA, and their respective metabolite(s), Absolute change in percent predicted forced expiratory volume in 1 second (ppFEV1) from baseline at Day 28, Absolute change in Cystic Fibrosis Questionnaire Revised (CFQ R) respiratory domain (RD) score from baseline at Day 28
Interventions
DRUGVX-828 tablet
DRUGVX-828 Placebo
DRUGVX-561 film-coated tablet
DRUGVx-661 Placebo
DRUGVX-661 50mg Tablet
DRUGVX-561 Placebo
DRUGVx-121/vx-661/vx-561 film-coated tablet Placebo
Sponsors
Vertex Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability, based on the assessment of adverse events (AEs), laboratory test results, standard 12 lead ECGs, and vital signs, Absolute change in sweat chloride (SwCl) concentrations from baseline through Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters of VX 828, TEZ, D IVA, and their respective metabolite(s), Absolute change in percent predicted forced expiratory volume in 1 second (ppFEV1) from baseline at Day 28, Absolute change in Cystic Fibrosis Questionnaire Revised (CFQ R) respiratory domain (RD) score from baseline at Day 28 | — |
Outcome results
None listed