Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis Patients

Key inclusion criteria (Parts 1 and 2) * Healthy female (of non-childbearing potential) and male subjects of 18 to 55 years of age (inclusive) * Body mass index (BMI) must be within the range of 15 to 30 kg/m2 * Oxygen saturation (O2) at screening must be ≥ 96% on room air. Key exclusion criteria (Parts 1 and 2) * Use of any prescription drugs or herbal supplements within four (4) weeks prior to dosing or within 5 half-lives of the drug, whichever is longer * Over-the-counter (OTC) medication (including vitamins, dietary supplements) within two (2) weeks prior to dosing * Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer * Unwilling to avoid direct sun exposure by covering exposed skin, using topical sun block and wearing sunglasses from the first dose of study drug to the end of participation in the study * Pregnant or nursing (lactating) women. Key inclusion criteria (Parts 3 and 4): * Male and female patients of 18 to 65 years of age (inclusive) with a confirmed diagnosis of cystic fibrosis as per the Cystic Fibrosis Foundation (CFF) consensus guidelines * Heterozygous with one allele represented as any CFTR mutation and the other allele must represent a class III, IV, V, VI CFTR mutation (Note: since the CFTR mutation, F508del, can be considered either a class II or III mutation, heterozygous CF patients that have one allele that contains F508del, must have the other allele contain a cla…