Study of Sulthiame (S-054502) in Participants With Renal Impairment and Matched Healthy Controls

Key Inclusion Criteria:

All Participants:

• Participants who are considered to be healthy (for normal renal function participants) or medically stable (for participants with renal impairment), as determined by medical evaluation including previous medical conditions/concurrent medical conditions, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiography (ECG) during the screening period and on Day -1. Participants with renal impairment should have no clinically significant changes (based on investigator clinical judgment) in previous medical conditions/concurrent medical conditions or laboratory values within 3 months prior to administration of the investigational intervention on Day 1.
• Body weight ≥ 60 kilograms (kg) for male and ≥ 50 kg for female and body mass index (BMI) within the range 18.5 to 40.0 (inclusive) kg/square meter (m^2) .

Participants With Renal Impairment (Groups A and B):

• Participants who have mild and moderate renal impairment based on estimated glomerular filtration rate (eGFR) calculated using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine formula and the participant's body surface area (BSA) at the screening visit (Day -28 to -2).

  • Mild renal impairment: 60 to < 90 milliliters (mL)/minute (min)
  • Moderate renal impairment: 30 to < 60 mL/min

• A stable medication regimen is required, defined as not starting new drug(s) or changing dosage(s) within 14 days prior to administration of the investigational intervention through the follow-up/early termination visit.

Healthy Participants With Normal Renal Function (Group C):

• Participants with clinical laboratory tests within normal reference range for the laboratory, or abnormal but considered not clinically significant by the investigator. Renal function based on eGFR, calculated based on the 2021 CKD EPI creatinine formula and the participant's BSA, must be normal (eGFR ≥ 90 mL/min) at the screening visit.
• Matched to an individual participant with moderate renal impairment (Group B) with respect to age (± 10 years), body weight (± 10 kg), and sex.

Key Exclusion Criteria:

All Participants:

• History or presence of/significant history of or current cardiovascular, respiratory, hepatic, gastrointestinal (GI), endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the investigational intervention; or interfering with the interpretation of data.
• History of GI surgery such as gastrectomy and enterectomy that could lead to clinically significant gastrointestinal dysfunction.
• Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• Participants with fluctuating or rapidly deteriorating renal function.
• Participation in any other clinical study or any other type of medical research involving administration of an investigational intervention (new chemical entity) within 28 days or 5 half-lives of the investigational intervention (if known) prior to dosing, whichever is longer.

Participants With Renal Impairment (Groups A and B):

• Participant with clinically significant laboratory values in the opinion of the investigator or outside the protocol-defined ranges or limits during the screening period or on Day -1.

Healthy Participants With Normal Renal Function (Group C):

• History or presence of/significant history of or current renal disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the investigational intervention; or interfering with the interpretation of data.

Note: Other protocol-defined inclusion and exclusion criteria may apply.