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This is a single-center, open-label, randomized, two way crossover study to investigate the food effect on the pharmacokinetics of ACT-541468 in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: ACT-541468 50 mg under fasted conditions | Experimental | Single oral dose administered on Day 1 under fasted conditions. |
|
| Treatment B: ACT-541468 50 mg under fed conditions | Experimental | Single oral dose administered on Day 1 administered after food intake. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT-541468 | Drug | ACT-541468 50 mg film-coated tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic endpoint: AUC0-24 | Area under the plasma concentration-time curve (AUC) from time zero to 24 h | Multiple timepoints; duration: up to 48 hours in each treatment period |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic endpoint: AUC0-inf | AUC from time zero to infinity | Multiple timepoints; duration: up to 48 hours in each treatment period |
| Pharmacokinetic endpoint: Cmax | Maximum plasma concentration |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Idorsia Pharmaceuticals Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CEPHA s.r.o. | Pilsen | 323 00 | Czechia |
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| ID | Term |
|---|---|
| C000634383 | daridorexant |
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Two way crossover
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| Multiple timepoints; duration: up to 48 hours in each treatment period |
| Pharmacokinetic endpoint: tmax | Time to reach maximum plasma concentration | Multiple timepoints; duration: up to 48 hours in each treatment period |
| Pharmacokinetic endpoint: t½ | Terminal elimination half-life | Multiple timepoints; duration: up to 48 hours in each treatment period |
| Treatment-emergent adverse events | From study treatment administration up to EOT; duration: up to 48 hours in each treatment period |
| Serious treatment-emergent adverse events | From study treatment administration up to EOT; duration: up to 48 hours in each treatment period |