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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002005-22 | EudraCT Number |
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This study is for research purposes only and is not intended to treat any medical condition. The purpose of this study is to evaluate the pharmacokinetics of 2 different formulations of ACT-709478 in healthy male participants. The participants will be treated in a crossover design with 2 different treatment periods. Pharmacokinetics (PK) is the study of the absorption and breakdown of the study drug in the body.
The duration of participation in this study is approximately 8 weeks from screening to the end of study visit. A screening visit is required within 21 to 3 days prior to the start of the study to determine whether the participant qualifies and is willing to enter in this research study. This study requires the participant to have two in-patient stays in the research clinic. Each in-patient stay is planned for 5 days (4 nights). Eleven days after each dose the participant will have an examination. There will be an in-between period (i.e., time between the end of period 1 and study treatment administration in Period 2) of 7 to 14 days. A safety follow-up telephone call for all participants who have received at least one study treatment will take place 30 to 40 days after the end of study examination or study discontinuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test drug formulation | Experimental | Test drug 60 mg single dose |
|
| Reference drug formulation | Active Comparator | 60 mg single dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT-709478 | Drug | 1 film-coated minitablet contains 2 mg of ACT-709478 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The area under the plasma concentration-time curve (AUC 0-t). | Multiple time points; duration for up to 264 hours in each treatment period. | |
| The area under the plasma concentration-time curve (AUC 0-inf) | Multiple time points; duration for up to 264 hours in each treatment period. | |
| The maximum plasma concentration (Cmax) | Multiple time points; duration for up to 264 hours in each treatment period. | |
| The time to reach Cmax (tmax) | Multiple time points; duration for up to 264 hours in each treatment period. | |
| The terminal elimination half-life (t1/2) | Multiple time points; duration for up to 264 hours in each treatment period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CEPHA s.r.o. | Pilsen | 323 00 | Czechia |
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| ID | Term |
|---|---|
| C000707407 | ACT-709478 |
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| ACT-709478 |
| Drug |
1 hard capsule contains 10 mg of ACT-709478. |
|