
Known history of, or current clinically significant arrhythmias. Are taking medications prohibited to be taken with the study treatment. Use of other investigational drugs within 5 half-lives prior to dosing of study treatment, or within 30 days, whichever is longer or longer if required by local regulations. Participants must maintain the same smoking status throughout the study (i.e. Must be a non-smoker or agree to smoke no more than 5 cigarettes (or equivalent) per day from Screening until the End of Study. Participants must weigh at least 50.0 kg and must have a body mass index (BMI) within the range of 18.0 to 38.0 kg/m2, inclusive, at Screening. Male and non-child bearing potential female participants, 18 to 75 years of age (inclusive) at Screening. The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic PK, safety, and tolerability of icenticaftor in participants with varying degrees of hepatic impairment. A safety follow-up contact will be done 30 days after administration of the study drug. The study is comprised of an up to 28-day screening period (Days -28 to -1), a baseline evaluation (Day -1) prior to treatment on Day 1, and a follow-up period of 7 days for pharmacokinetics (PK) sample collection (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose). Each participant will receive a single oral dose of 300 mg of icenticaftor (QBW251) on Day 1 under fasting conditions. Up to a total of 48 participants will be enrolled in this study (approximately 8 in each mild, moderate, severe hepatic impairment groups), and up to 24 healthy control subjects).
Subjects with normal hepatic function will be matched with subjects with hepatic impairment for gender, age (± 10 years), body weight (± 15%), and smoking status (smoker or non-smoker).
The study employs a single-dose, open-label design in subjects with mild, moderate, or severe hepatic impairment along with matched healthy control subjects with normal hepatic function. This is a Phase 1, multi-center study with parallel groups.
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