Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT04052360
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04052360
Study Brief:
Protocol Section:
NCT04052360