Single Oral Dose of 4 mg Cenerimod in Healthy Japanese and Caucasian Subjects

Inclusion criteria

• Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
• Body mass index of 18.0 to 28.0 kg/m^2 (inclusive) at the screening.
• Ability to communicate well with the investigator, in a language understandable to the subject, and to understand and comply with the requirements of the study.
• No clinically relevant findings on the physical examination at screening.
• Systolic blood pressure 100 to 145 mmHg, diastolic blood pressure 50 to 90 mmHg, and pulse rate 55 to 90 bpm (inclusive), measured on the same arm, after 5 min in the supine position at screening and on admission.
• 12-lead ECG without clinically relevant abnormalities, measured after 5 min in the supine position at Screening and on admission.
• No clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry, and urinalysis) at screening and on admission.
• Negative results from urine drug screen and breath alcohol tests at screening and on admission.
• Subjects must be of Caucasian or Japanese ethnicity.

Exclusion criteria

• Previous exposure to cenerimod.
• Known hypersensitivity or allergy to natural rubber latex, to or any of the excipients.
• History of major medical or surgical disorders which are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed).
• Acute, ongoing, recurrent, or chronic systemic disease able to interfere with the evaluation.
• Clinically relevant history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
• Lymphopenia (less than 1.0 x 10^9 cells/L) at screening and on admission.
• Familial history of sick-sinus syndrome.
• Any cardiac condition or illness (including Electrocardiogram (ECG) abnormalities with a potential to increase the cardiac risk.
• Familial history of sick-sinus syndrome.
• Any recent immunosuppressive treatment.
• History or clinical evidence of alcoholism or drug abuse.
• Excessive caffeine consumption, defined as 800 mg or more per day at screening.
• Nicotine consumption within 3 months prior to screening and inability to refrain from nicotine consumption.
• Previous treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals).
• Viral, fungal, bacterial or protozoal infection and / or serology.
• Legal incapacity or limited legal capacity at screening.