The Effect of Severe Kidney Impairment on Cenerimod Pharmacokinetics

Exclusion Criteria

• •Pregnant or lactating women.
• •Participation in a clinical study involving study treatment administration within 3 months prior to screening or participation in more than 2 clinical studies within 1 year prior to Screening.
• •Previous exposure to cenerimod.
• •Known hypersensitivity to any excipients of the treatment formulation.
• •Clinically relevant abnormalities on a 12-lead electrocardiogram at Screening and Day -1.
• •Previous treatment with anti-arrhythmic medications of class Ia or III within 2 weeks or 5 half-lives, whichever is longer, prior to study treatment administration.
• •History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study treatment except for renal disease, appendectomy, herniotomy, or cholecystectomy.
• •Aspartate aminotransferase and alanine aminotransferase above the upper limit of normal.
• •Legal incapacity or limited legal capacity at Screening.
• •Presence of severe cardiac disease.
• •End-stage renal disease that requires dialysis.
• •History of severe renal artery stenosis.
• •Serum potassium concentration \> 5.5 mmol/L.
• •Presence of unstable diabetes mellitus.
• •Strict fluid restriction.
• •Clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry, and urinalysis) except for those related to renal impairment at Screening and on Day -1.
• •Clinically relevant findings on the physical examination at Screening.
• •Clinically relevant findings in clinical laboratory tests.