Key inclusion and exclusion criteria

Inclusion criteriaExclusion criteria
Randomised controlled studies: VX17-659-102, VX17-445-102, VX17-659-103 and VX17-445-103
 SexMale or femalePregnant or nursing female
 Age years≥12<12
CFTR genotypeF508del/MF; F508del/F508delAll other genotypes
 Disease statusStable CF disease; FEV1 % pred ≥40% and ≤90%Acute respiratory infection, pulmonary exacerbations or changes in therapy for sinopulmonary disease#
 Concomitant medicationsWillingness to remain on a stable CF treatment regimenUse of restricted medications within the specified window before the first dose of study drug
 ConsentWritten informed consentNA
Open-label extension studies: VX17-659-105 and VX17-445-105
 Parent studyCompletion of study drug treatment or interruption of study drug but with subsequent completion of the parent studyDrug intolerance in a parent study that, in the opinion of the investigator, would pose an additional risk to the patient; current participation in an investigational drug trial (other than a parent study)

CFTR: cystic fibrosis transmembrane conductance regulator; MF: minimal function; FEV1: forced expiratory volume in 1 s; NA: not applicable; CYP3A: cytochrome P450 3A. #: within 28 days before the first dose of study drug; : restricted medications within 14 days of the first dose of study drug include moderate and strong CYP3A inducers, moderate and strong CYP3A inhibitors, and sensitive organic anion transporting polypeptide 1B1 substrates.