Key inclusion and exclusion criteria
| Inclusion criteria | Exclusion criteria | |
| Randomised controlled studies: VX17-659-102, VX17-445-102, VX17-659-103 and VX17-445-103 | ||
| Sex | Male or female | Pregnant or nursing female |
| Age years | ≥12 | <12 |
| CFTR genotype | F508del/MF; F508del/F508del | All other genotypes |
| Disease status | Stable CF disease; FEV1 % pred ≥40% and ≤90% | Acute respiratory infection, pulmonary exacerbations or changes in therapy for sinopulmonary disease# |
| Concomitant medications | Willingness to remain on a stable CF treatment regimen | Use of restricted medications within the specified window before the first dose of study drug¶ |
| Consent | Written informed consent | NA |
| Open-label extension studies: VX17-659-105 and VX17-445-105 | ||
| Parent study | Completion of study drug treatment or interruption of study drug but with subsequent completion of the parent study | Drug 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.