A Study to Evaluate Cenerimod in Healthy Male Subjects
- Registration Number
- NCT02914223
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Extended observation period Cenerimod 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 Treatment and observation period Cenerimod 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
- Primary Outcome Measures
Name Time Method 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
Name Time Method t1/2 (terminal half-life) From baseline up to a maximum of 99 days Cmax (maximum plasma concentration) of 14C-radioactivity in whole blood and plasma From baseline up to a maximum of 99 days Cmax is derived from the observed plasma concentration-time curves
tmax (time to reach Cmax) of 14C-radioactivity in whole blood and plasma From baseline up to a maximum of 99 days Tmax is derived from the observed plasma concentration-time curves
Area under the plasma concentration-time curve (AUC) of 14C-radioactivity in whole blood and plasma From baseline up to a maximum of 99 days 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
Incidence of safety events of interest From baseline up to a maximum of 99 days Events of interest are any abnormalities in ECG, vital signs or laboratory test results
Number of participants with adverse events (AEs) From baseline up to a maximum of 99 days Treatment-emergent AEs and treatment emergent serious AEs
Cenerimod metabolites profiling in plasma From baseline up to a maximum of 99 days Relative abundance expressed as percent of cenerimod
Cenerimod metabolites profiling in urine From baseline up to a maximum of 99 days Relative abundance expressed as percent of cenerimod
Cenerimod metabolites profiling in feces From baseline up to a maximum of 99 days Relative abundance expressed as percent of cenerimod
Trial Locations
- Locations (1)
PRA Health Science
🇳🇱Groningen, Netherlands