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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-006002-23 | EudraCT Number |
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This is a prospective, open-label, single-dose, phase 1 study, to assess the effect of mild and moderate hepatic impairment on the pharmacokinetics of cenerimod (ACT-334441).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Participants with mild hepatic impairment | Experimental | Participants with mild hepatic impairment (Child-Pugh Score of 5 to 6). |
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| Group B: Participants with moderate hepatic impairment | Experimental | Participants with moderate hepatic impairment (Child-Pugh Score of 7 to 9). |
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| Group C:Healthy participants | Experimental | Healthy participants will be matched to the participants with hepatic impairment based on age and body weight. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cenerimod | Drug | A single oral dose of 0.5 mg. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curves (AUC0-t): cenerimod | Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98. | |
| Area under the plasma concentration-time curve from zero to infinity (AUC0-inf): cenerimod | Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98. | |
| Maximum plasma concentration (Cmax): cenerimod. | Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98. | |
| Time to reach Cmax (tmax): cenerimod | Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98. | |
| Terminal half-life (t½): cenerimod | Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98. | |
| Plasma protein binding of cenerimod | Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98. | |
| Apparent clearance (CL/F) of cenerimod | Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98. | |
| Apparent volume of distribution (Vz/F) of cenerimod | Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98. |
| Measure | Description | Time Frame |
|---|---|---|
| Total lymphocyte count | Multiple sampling at predefined times on Day 1 (pre-dose) up to Day 98. | |
| Change from baseline at each time point of measurement in electrocardiogram QT interval | Pre-defined times on Day 1 (pre-dose) up to Day 105. |
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Inclusion Criteria:
Exclusion Criteria:
General (Group A, B and C)
Additional exclusion criteria for participants with hepatic impairment (Group A and B)
Additional exclusion criteria for healthy subjects (Group C)
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Viatris Innovation GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRU Hungary | Kistarcsa | H2143 | Hungary | |||
| BlueClinical Phase 1 Hospital de Prelado |
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| ID | Term |
|---|---|
| C000709569 | cenerimod |
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The 3 groups will be sequentially studied. Dosing will start in the participants with mild hepatic impairment.
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| Change from baseline in body weight | Day -1 and Day 105. |
| Change from baseline in systolic and diastolic blood pressure (in the supine position) | Predefined times on Day 1 (pre-dose) up to Day 105. |
| Incidence of abnormal laboratory test results | Multiple sampling at predefined times on Day 1 (pre-dose) up to Day 105. |
| Adverse events and serious adverse events | Day 1 up to Day 105. |
| Porto |
| 4250-449 |
| Portugal |