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This study examined the drug VX-445, alone or together with other drugs (such as TEZ/IVA), in healthy volunteers and in people with cystic fibrosis. Depending on the part, it enrolled healthy volunteers aged 18 to 55 or patients with an eligible CFTR genotype (carrying F508del). It was carried out in Phase 1/Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Key Inclusion Criteria: Parts A, B, and C: * Female subjects must be of non-childbearing potential. * Between the ages of 18 and 55 years, inclusive. * Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and a total body weight \>50 kg Parts D, E, and F: * Body weight ≥35 kg. * Subjects must have an eligible CFTR genotype: * Parts D and F: Heterozygous for F508del and an MF mutation (F/MF) * Part E: Homozygous for F508del (F/F) * FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height. Key Exclusion Criteria: Parts A, B, and C: * Any condition possibly affecting drug absorption. * History of febrile illness within 14 days before the first study drug dose. * Glucose-6-phosphate dehydrogenase (G6PD) deficiency. Parts D, E, and F: * History of clinically significant cirrhosis with or without portal hypertension. * Glucose-6-phosphate dehydrogenase (G6PD) deficiency. * Lung infection with organisms associated with a more rapid decline in pulmonary status. * History of solid organ or hematological transplantation. Other protocol defined Inclusion/Exclusion criteria may apply.