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The goal of this clinical trial is to learn about the absolute bioavailability of cenerimod in healthy participants. It will also provide information about the safety of cenerimod.
Participants will receive one tablet with cenerimod, followed by an intravenous (i.v.) infusion with a 14C-radiolabeled cenerimod microtracer (cenerimod with a very low dose of radioactivity) 6 hours later.
Participants will stay at the clinic for a total of 4 days, and will return to the clinic for further tests over the course of approximately 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cenerimod | Experimental | Cenerimod is administered as a single oral dose followed by a single i.v. radiolabeled dose 6 h later. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cenerimod (oral) | Drug | A single dose of cenerimod, administered as an oral tablet at a strength of 4 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Absolute bioavailability | Absolute bioavailability of a single oral dose of 4 mg cenerimod, calculated as: area under the plasma concentration-time curve from zero to infinity (AUC0-∞) of the oral dose / AUC0-∞ of the intravenous dose, normalized by dose. | Up to 98 days post-dose |
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Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Viatris Innovation GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaceutical Research Associates Group B.V. | Groningen | 9728 | Netherlands |
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| ID | Term |
|---|---|
| C000709569 | cenerimod |
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| 14C-Cenerimod (i.v.) | Drug | A single i.v. dose of 7.5 µg 14C-radiolabeled cenerimod (34.5 kBq), with administration starting 6 h after administration of the oral dose. |
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