the effect of severe kidney impairment on cenerimod pharmacokinetics

Conditions: Healthy; Renal Impairment

Summary: to investigate the pk of cenerimod in participants with severe renal impairment as compared to healthy control participants.


Eligibility criteria:
inclusion criteria: * signed informed consent in a language understandable to the participant prior to any study-mandated procedure. * women of childbearing potential must have a negative serum pregnancy test at screening, a negative urine pregnancy test on day -1, and agree to consistently and correctly use a highly effective method of contraception. * women of non-childbearing potential. * body mass index of 18.0 to 35.0 kg/m2 (inclusive) at screening * negative sars-cov-2 reverse transcription polymerase chain reaction test on day -1. additional inclusion criteria for participants with severe renal impairment * estimated glomerular filtration rate (egfr) at screening using the modification of diet in renal disease formula less-than 30 ml/min/1.73 m2 for participants with renal impairment. the egfr value should be confirmed on day -1. * systolic blood pressure (sbp) 100 to 180 mmhg, diastolic bp (dbp) 50 to 105 mmhg, and pulse rate 60 to 100 bpm (inclusive), on day 1 pre-dose. * stable concomitant medications for at least 3 weeks prior to screening and up to day 1. * aspartate aminotransferase and alanine aminotransferase above the upper limit of normal. * clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry, and urinanalysis) except for those related to renal impairment at screening and on day-1. additional inclusion criteria for control participants * egfr at screening using the modification of diet in renal disease formula of ≥ 90 ml/min/1.73 m2. * sbp 90 to 139 mmhg, dbp 60 to 89 mmhg, and pulse rate 60 to 99 bpm, measured on the same arm, after 5 min in the supine position at screening and on day 1 pre-dose. 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. additional exclusion criteria for participants with severe renal impairment: * 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. additional exclusion criteria for control participants * clinically relevant findings on the physical examination at screening. * clinically relevant findings in clinical laboratory tests.