Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment and observation period | Experimental | 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 |
|
| Extended observation period | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cenerimod | Drug | Oral formulation of cenerimod (2mg) containing 100 μCi (3.7 MBq) of 14C-radiolabeled cenerimod |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Viatris Innovation GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Science | Groningen | 9728 NZ | Netherlands |
Not provided
| ID | Term |
|---|---|
| C000709569 | cenerimod |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |