A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Severe Renal Impairment Compared to Matched Healthy Participants.

Inclusion Criteria

• •All participants (Group 1 \& 2)
• •Male and non-childbearing potential female participants 18 to 75 years of age, inclusive, at Screening.
• •Must be a non-smoker or a light smoker who smokes no more than 10 cigarettes (or equivalent, including use of nicotine products) per day, at Screening. Smokers must agree to smoke no more than 5 cigarettes (or equivalent) per day from check-in until after Study Completion evaluations.
• •Participants with severe RI (Group 1)
• •Must weigh at least 50 kg to participate in the study and must have a body mass index (BMI) within the range of 18.0 to 35.0 kg/m2, inclusive, at Screening.
• •Seated vital signs must be within the following ranges at Screening and Baseline:
• •1. body temperature, 35.0 to 37.5°C, inclusive.
• •2. systolic blood pressure, 90 to 159 mmHg, inclusive.
• •3. diastolic blood pressure, 60 to 99 mmHg, inclusive.
• •4. pulse rate, 50 to 99 bpm, inclusive.
• •Have impaired renal function as determined by eGFR using the CKD-EPI Creatinine - Cystatin C equation (2021), in the following group at Screening: severe RI; eGFR \<30 mL/min, not requiring dialysis.
• •Have stable renal function with no clinically significant change in renal status prior to first dosing of study treatment as determined by the Investigator and is not currently or has not been previously on hemodialysis for at least 1 year. Participants with other stable medical disorders such as controlled diabetes, hyperlipidemia, hypothyroidism, arterial hypertension etc., may be eligible as long as they are considered appropriate for enrollment as determined by the Investigator by past medical history, physical examination, ECG, and clinical laboratory tests at Screening.
• •Healthy control participants (Group 2)
• •Each healthy participant must match the age (± 10 years), body weight (± 20%), race, ethnicity and sex of an individual participant in Group 1.
• •Must weigh at least 50 kg to participate in the study and must have a BMI within the range of 18.0 to 35.0 kg/m2 inclusive, at Screening.
• •Must be in good health as determined by medical history, physical examination, ECG, vital signs and clinical laboratory tests at Screening.
• •Has normal renal function with eGFR greater than or equal to 90 mL/min, determined using the CKD-EPI Creatinine - Cystatin C equation (2021) at Screening. Actual creatinine clearance computed over a 24-hour urine collection may be used in place of or in conjunction with the CKD-EPI Creatinine - Cystatin C equation (2021), at the Investigator's discretion.