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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000336-34 | EudraCT Number |
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The primary purpose of this study is to evaluate the safety and tolerability of ascending multiple doses of ACT-709478 in healthy male and female subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACT-709478 | Experimental | 40 subjects will receive multiple doses of ACT-709478 at the planned dose levels of 30, 60, 100, and 200 mg. Each dose level will be investigated in a new cohort of 10 healthy male and female subjects (4 male subjects on active drug and 1 on placebo, 4 female subjects on active drug and 1 on placebo) undergoing one treatment period with a once daily dosing scheme. |
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| Placebo | Placebo Comparator | Matched placebo administered accordingly |
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| Midazolam | Other | 4 mg taken by mouth on Day 1 of the corresponding cohort |
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| ACT-709478 combined with Midazolam | Experimental | On Day 22 and Day 30, midazolam (4 mg) and ACT-709478 (60 mg or 100 mg) to be co-administered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT-709478 | Drug | Hard gelatine capsules for oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events | The percentage of subjects with treatment-emergent adverse events will be reported | up to Day 23 |
| Changes from baseline in vital signs | Vital signs include diastolic and systolic blood pressure and pulse rate | up to Day 23 |
| 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 23 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of ACT-709478 | Cmax is derived from the observed plasma concentration-time curves | up to Day 23 |
| Time to reach Cmax (tmax) of ACT-709478 | tmax is directly derived from the observed plasma concentrations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Idorsia Pharmaceuticals Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel | Berlin | 14050 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31994022 | Derived | Richard M, Kaufmann P, Ort M, Kornberger R, Dingemanse J. Multiple-Ascending Dose Study in Healthy Subjects to Assess the Pharmacokinetics, Tolerability, and CYP3A4 Interaction Potential of the T-Type Calcium Channel Blocker ACT-709478, A Potential New Antiepileptic Drug. CNS Drugs. 2020 Mar;34(3):311-323. doi: 10.1007/s40263-019-00697-1. |
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| ID | Term |
|---|---|
| C000707407 | ACT-709478 |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo |
| Drug |
Placebo capsules matching ACT-709478 capsules |
|
| Midazolam | Drug | Midazolam oral solution (2 mg/mL) applied with a syringe |
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| ACT-709478 combined with midazolam | Drug | Hard gelatine capsules for oral administration (ACT-709478) to be taken first followed by Midazolam oral solution (2 mg/mL) applied with a syringe |
|
| up to Day 23 |
| Terminal half-life (t1/2) of ACT-709478 | t1/2 is calculated from the terminal rate constant obtained from the plasma concentrations-time curves | up to Day 23 |
| Area under the plasma concentration-time curve AUC(tau) of ACT-709478 | AUCtau is defined as the area under the plasma concentration-time curve during one dosing interval | up to Day 23 |
| Area under the plasma concentration-time curve AUC(tau) of midazolam | AUCtau is defined as the area under the plasma concentration-time curve during one dosing interval | 24 hours after dosing on Day 1, Day 22 and Day 30 |
| Time to reach Cmax (tmax) | tmax is directly derived from the observed plasma concentrations | 24 hours after dosing on Day 1, Day 22 and Day 30 |
| Maximum plasma concentration (Cmax) of ACT-709478 | Cmax is derived from the observed plasma concentration-time curves | 24 hours after dosing on Day 1, Day 22 and Day 30 |
| D006571 | Heterocyclic Compounds |