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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001522-21 | EudraCT Number |
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To investigate the PK of cenerimod in participants with severe renal impairment as compared to healthy control participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (severe renal function impairment) | Experimental | Eight (8) participants with severe renal impairment. |
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| Group B (healthy) | Experimental | Eight (8) control participants, matched to the 8 severe renal impaired participants enrolled in Group A. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cenerimod | Drug | A single oral dose of 0.5 mg cenerimod will be administered as a film-coated tablet in the morning of Day 1 under fasted conditions |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) from time zero to time t of the last measured concentration above the limit of quantification (AUC0-t) of cenerimod | Total duration: up to 52 days | |
| Area under the plasma concentration-time curve (AUC from 0 to infinity) of cenerimod | Total duration: up to 52 days | |
| The maximum plasma concentration (Cmax) of cenerimod | Total duration: up to 52 days | |
| The time to reach Cmax (tmax) of cenerimod | Total duration: up to 52 days | |
| Terminal half-life (t½) of cenerimod | Total duration: up to 52 days | |
| Apparent oral clearance (CL/F) of cenerimod | Total duration: up to 52 days | |
| Extent of cenerimod protein plasma binding (PPB) | Total duration: up to 52 days | |
| Apparent volume of distribution (Vz/F) of cenerimod | Total duration: up to 52 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total lymphocyte count count. | Total duration: up to 66 days | |
| Change from baseline at each time point of measurement in electrocardiogram QT interval | Total duration: up to 66 days | |
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Inclusion Criteria:
Additional inclusion criteria for participants with severe renal impairment
Additional inclusion criteria for control participants
Exclusion Criteria:
Additional exclusion criteria for participants with severe renal impairment:
Additional exclusion criteria for control participants
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Viatris Innovation GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BlueClinical Phase 1 Hospital de Prelado | Porto | 4250-449 | Portugal |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000709569 | cenerimod |
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| Change from baseline in body weight |
| Total duration: up to 66 days |
| Change from baseline in systolic and diastolic blood pressure (in the supine position) | Total duration: up to 66 days |
| Incidence of abnormal laboratory test results | Total duration: up to 66 days |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |