Pharmacokinetic Study of Icenticaftor in Participants With Hepatic Impairment

This is an interventional treatment trial for Hepatic Failure focused on measuring Hepatic impairment, Child-Pugh classification, Icenticaftor, QBW251 Read More

All Participants:

Inclusion Criteria:

• Male and non-child bearing potential female participants, 18 to 75 years of age (inclusive) at Screening.
• 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.
• 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 maintain the same smoking status throughout the study (i.e. smoker or non smoker).

Exclusion Criteria:

• 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.
• Are taking medications prohibited to be taken with the study treatment
• Known history of, or current clinically significant arrhythmias. Have clinically significant ECG abnormality or history of long-QT syndrome or whose QT interval corrected by Fridericia's formula (QTcF) is prolonged (> 480 msec) at Screening. Participants having myocardial infarction ≥ 5 years ago are eligible to participate.
• Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection.

Healthy Participants:

• Each participant must match in age (± 10 years), gender, weight (± 15%), and smoking status to participants in Group 2, 3, or 4.
• Seated vital signs must be within the following ranges at Screening and Baseline:
• Body temperature, 35.0 to 37.5°C, inclusive.
• Systolic blood pressure, 89 to 149 mmHg, inclusive.
• Diastolic blood pressure, 50 to 89 mmHg, inclusive.
• Pulse rate, 40 to 90 bpm, inclusive.
• Participants must be in good health as determined by medical history, physical examination, ECG, and clinical laboratory tests at Screening.

Exclusion Criteria:

• Liver disease or liver injury as indicated by abnormal liver function tests.
• Chronic infection with HBV or HCV.
• History or presence of impaired renal function.

Hepatic Impairment Participants:

Inclusion Criteria:

• Seated vital signs must be within the following ranges at Screening and Baseline:
• Body temperature, 35.0 to 37.5°C, inclusive.
• Systolic blood pressure, 89 to 159 mmHg, inclusive.
• Diastolic blood pressure, 50 to 99 mmHg, inclusive.
• Pulse rate, 50 to 99 bpm, inclusive.
• Hepatic impairment as defined by the Child-Pugh classification for severity of liver disease

Exclusion Criteria:

• Have severe complications of liver disease within the preceding 3 months of Screening.
• Emergency room visit or hospitalization due to liver disease within the preceding 3 months of Screening.
• Have received liver transplant at any time in the past.
• Have encephalopathy Grade 3 or worse within 28 days prior to dosing of study treatment.
• Have acute hepatitis B (HBV) or hepatitis C (HCV) infection.
• Clinically significant abnormal findings in physical examination or clinical laboratory evaluations not consistent with known liver disease.

Other protocol-defined inclusion/exclusion criteria may apply