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So far, ACT-541468 has been studied mainly in Caucasian subjects. The present study will bridge results obtained in Caucasian subjects to those in Japanese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACT-541468 (25 mg) | Experimental | 8 Japanese and 8 Caucasian subjects will receive 25 mg (1 capsule) of ACT-541468 once daily for 5 days |
|
| ACT-541468 (50 mg) | Experimental | 8 Japanese and 8 Caucasian subjects will receive 50 mg (2 capsules) of ACT-541468 once daily for 5 days |
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| Placebo | Placebo Comparator | 2 Japanese / 2 Caucasian subjects will receive 1 placebo capsule to match subjects in the ACT-541468 (25 mg) group and 2 other Japanese / 2 Caucasian subjects will receive 2 placebo capsules to match subjects in the ACT-541468 (50 mg) group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT-541468 | Drug | Capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of ACT-541468 | The geometric mean Cmax values will be calculated based on pharmacokinetic (PK) blood sampling | From Day1 pre-dose to 48 hours after the last dose on Day 5 |
| Area under the plasma concentration-time curves during a dosing interval [AUC(0-24)] of ACT-541468 | The geometric mean AUC(0-24) values will be calculated based on PK blood sampling | From Day1 pre-dose to 48 hours after the last dose on Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach Cmax (tmax) of ACT-541468 | The median tmax values will be calculated based on PK blood sampling | From Day1 pre-dose to 48 hours after the last dose on Day 5 |
| Terminal half-life [t(1/2)] of ACT-541468 |
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Key Inclusion Criteria:
Japanese subjects only:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clemens Muehlan | Actelion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Human Drug Research | Leiden | Netherlands |
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| ID | Term |
|---|---|
| C000634383 | daridorexant |
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| placebo |
| Drug |
Matching placebo capsule |
|
The geometric mean t(1/2) values will be calculated based on PK blood sampling
| From Day1 pre-dose to 48 hours after the last dose on Day 5 |
| Area under the plasma concentration-time curves from time 0 to 8 h [AUC(0-8)] | The geometric mean AUC(0-8) values will be calculated based on PK blood sampling | From Day1 pre-dose to 48 hours after the last dose on Day 5 |
| Incidence of treatment-emergent adverse events | The percentage of subjects with treatment-emergent adverse events will be reported | Up to Day 7 (end of study) |
| Incidence of adverse events leading to premature discontinuation of study treatment | The number of subjects who prematurely discontinued the study treatment due to an adverse event will be reported | Up to Day 5 |
| Incidence of any clinical relevant findings in ECG variables | The number of subjects with any treatment-emergent electrocardiogram (ECG) abnormalities will be reported | Up to Day 7 (end of study) |