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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000653-27 | EudraCT Number |
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A study in healthy male subjects to investigate the effect of famotidine and efavirenz on the way the body takes up, distributes, and gets rid of daridorexant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: Daridorexant | Experimental | Single dose of 50 mg daridorexant |
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| Treatment B: Famotidine & daridorexant | Experimental | Single dose of 40 mg famotidine followed 3 h later by a single dose of 50 mg daridorexant |
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| Treatment C: Efavirenz | Experimental | 600 mg efavirenz once daily in the evening from Day 5 to Day 14 |
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| Treatment D: Daridorexant & efavirenz | Experimental | Single dose of 50 mg daridorexant in the morning of Day 15 followed by a single dose of 600 mg efavirenz in the evening of Days 15 and 16 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daridorexant | Drug | Daridorexant will be administered orally as 1 film-coated tablet of 50 mg strength to be taken in the morning under fasted conditions. |
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| Measure | Description | Time Frame |
|---|---|---|
| PK parameter of daridorexant: Maximum plasma concentration (Cmax) | Various time points during Treatment A through D (Total duration: up to 3 weeks). | |
| PK parameter of daridorexant: Time to reach Cmax (tmax) | Various time points during Treatment A through D (Total duration: up to 3 weeks). | |
| PK parameter of daridorexant: AUC from zero to infinity (AUC0-inf) | Various time points during Treatment A through D (Total duration: up to 3 weeks). | |
| PK parameter of daridorexant: AUC from zero to 48 hours (AUC0-48) | Various time points during Treatment A through D (Total duration: up to 3 weeks). | |
| PK parameter of daridorexant: Terminal elimination half-life (t½) | Various time points during Treatment A through D (Total duration: up to 3 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent (S)AEs | Up to EOP for each of the Periods 1 to 3 and up to EOS for Period 4 (Total duration: up to 3 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials Study Director | Idorsia Pharmaceuticals Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Mannheim GmbH | Mannheim | 68167 | Germany |
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4 treatment arms in 2 sequences, ABCD or BACD.
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| Famotidine | Drug | Famotidine will be administered orally as 1 film-coated tablet of 40 mg strength to be taken in the morning under fasted conditions. |
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| Efavirenz | Drug | Efavirenz will be administered orally as 1 film-coated tablet of 600 mg strength o.d. in the evening. |
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| ID | Term |
|---|---|
| C000634383 | daridorexant |
| D015738 | Famotidine |
| C098320 | efavirenz |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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