Status:
COMPLETED
Single Oral Dose of 4 mg Cenerimod in Healthy Japanese and Caucasian Subjects
Lead Sponsor:
Viatris Innovation GmbH
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief Summary
This study is for research purposes only and is not intended to treat any medical condition. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynami...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04052360
Start Date
August 7 2019
End Date
November 2 2019
Last Update
September 22 2025
Active Locations (1)
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1
Anaheim Clinical Trials
Anaheim, California, United States, 92801