A Study to Evaluate Cenerimod in Healthy Male Subjects

Study Overview
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Brief Summary
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The main objective of the study is to investigate the rate and routes of elimination of cenerimod and the mass balance in urine, feces, and expired air

Official Title
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Single-center, Open-label Study With 14C-radiolabeled Cenerimod to Investigate the Mass Balance, Pharmacokinetics, and Metabolism Following Single Oral Administration to Healthy Male Subjects

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: Cenerimod


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent in a language understandable to the subject prior to any study-mandated procedure Healthy male subjects aged between 45 and 65 years (inclusive) at screening No clinically significant findings on the physical examination at screening Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at screening Systolic blood pressure (SBP) 100-145 mmHg and diastolic blood pressure (DBP) 50-90 mmHg, measured on either arm, after 5 min in the supine position at screening and at Day 1 pre-dose Heart rate (HR) 55-90 bpm (inclusive) measured with 12-lead ECG after 5 min in the supine position at screening and at Day 1 pre-dose Exclusion Criteria: Known hypersensitivity to cenerimod or to S1P receptor modulators, or to any excipients of the cenerimod drug formulation 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 (appendectomy and herniotomy allowed, cholecystectomy not allowed) History or clinical evidence suggestive of active or latent tuberculosis including a positive QuantiFERON®-TB test at screening Any cardiac condition or illness (including 12-lead ECG abnormalities) with a potential to increase the cardiac risk of the subject based on the standard 12-lead ECG at screening and at Day 1 pre-dose Participation in another study with a radiation burden of > 0.1 mSv and ≤ 1 mSv in the period of 1 year prior to screening; a radiation burden of ≥ 1.1 mSv and ≤ 2 mSv in the period of 2 years prior to screening, etc. (add 1 year per 1 mSv) Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol Any immunosuppressive treatment within 6 weeks or within 5 elimination half-lives of the immunosuppressive treatment, whichever is longer, before study treatment administration

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment and observation period<br>On Day 1, subjects will receive a single oral dose of 2 mg 14C-radiolabeled cenerimod. Subjects will be followed for 21 days during which blood, urine, feces, and expired air samples will be collected | Drug: Cenerimod<br>* Oral formulation of cenerimod (2mg) containing 100 μCi (3.7 MBq) of 14C-radiolabeled cenerimod<br>|
| Experimental: Extended observation period<br>In case, radioactivity recovery does not meet the stopping criteria described in the protocol, the subjects will have to come for a maximum of 7 24-h in-clinic visits during which blood, urine, feces, and expired air samples will be collected | Drug: Cenerimod<br>* Oral formulation of cenerimod (2mg) containing 100 μCi (3.7 MBq) of 14C-radiolabeled cenerimod<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative excretion calculated by summing up the daily radioactivity excretion measured by means of liquid scintillation counting in urine, feces, and expired air (if applicable) |  | From baseline up to a maximum of 99 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (maximum plasma concentration) of 14C-radioactivity in whole blood and plasma | Cmax is derived from the observed plasma concentration-time curves | From baseline up to a maximum of 99 days | 
| tmax (time to reach Cmax) of 14C-radioactivity in whole blood and plasma | Tmax is derived from the observed plasma concentration-time curves | From baseline up to a maximum of 99 days | 
| t1/2 (terminal half-life) |  | From baseline up to a maximum of 99 days | 
| Area under the plasma concentration-time curve (AUC) of 14C-radioactivity in whole blood and plasma | AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification and from zero to infinity | From baseline up to a maximum of 99 days | 
| Incidence of safety events of interest | Events of interest are any abnormalities in ECG, vital signs or laboratory test results | From baseline up to a maximum of 99 days | 
| Number of participants with adverse events (AEs) | Treatment-emergent AEs and treatment emergent serious AEs | From baseline up to a maximum of 99 days | 
| Cenerimod metabolites profiling in plasma | Relative abundance expressed as percent of cenerimod | From baseline up to a maximum of 99 days | 
| Cenerimod metabolites profiling in urine | Relative abundance expressed as percent of cenerimod | From baseline up to a maximum of 99 days | 
| Cenerimod metabolites profiling in feces | Relative abundance expressed as percent of cenerimod | From baseline up to a maximum of 99 days |