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The primary purpose of this first-in-man study is to investigate whether a new drug for neurological disorders is safe and well-tolerated when administered orally to healthy adults
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AC-082, Single Ascending Dose | Experimental | Subjects receive AC-082 at different single dose levels in a sequential manner, starting from 10 mg (number of cohorts and dose levels will depend on the safety and pharmacokinetic results of the previous cohort). Each subject can participate in only one dose level |
|
| Placebo, Single Ascending Dose | Placebo Comparator | Subjects receive a single dose of the matched placebo |
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| AC-082, Multiple Ascending Dose | Experimental | Subjects receive AC-082 at different dose levels for 4 consecutive days in a sequential manner (dose levels and duration to be adapted according to the results of the single ascending dose cohorts). Each subject can participate in only one dose level |
|
| Placebo, Multiple Ascending Dose | Placebo Comparator | Subjects receive the matched placebo for 4 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC-082 | Drug | Hard gelatin capsules for oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Treatment-emergent adverse events and treatment-emergent serious adverse events | Up to end of study (up to Day 11) |
| Changes from baseline in vital signs | Vital signs include diastolic and systolic blood pressure and pulse rate | Up to end of study (up to Day 11) |
| Changes from baseline in ECG variables | ECG variables are to be recorded at rest using a standard 12-lead ECG | Up to end of study (up to day 11) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) following single ascending doses | Cmax is derived from the observed plasma concentration-time curves | From pre-dose on Day 1 to 96 hours post dose |
| Time to reach Cmax (tmax) following single ascending doses |
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Key inclusion Criteria:
Key exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karine Litherland, PhD | Actelion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site | Berlin | 14050 | Germany |
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| Placebo | Drug | Matched placebo capsules for oral administration |
|
tmax is derived from the observed plasma concentration-time curves
| From pre-dose on Day 1 to 96 hours post dose |
| Terminal half-life [t(1/2)] following single ascending doses | From pre-dose on Day 1 to 96 hours post dose |
| Area under the plasma concentration-time curve (AUC) following single ascending doses | AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification [AUC(0-t)] and from zero to infinity [AUC(0-inf)] | From pre-dose on Day 1 to 96 hours post dose |
| Maximum plasma concentration (Cmax) following multiple ascending doses | Up to 96 hours following the last dose administration on Day 4 |
| Time to reach Cmax (tmax) following multiple ascending doses | Up to 96 hours following the last dose administration on Day 4 |
| Terminal half-life [t(1/2)] following multiple ascending doses | t(1/2) on the last day of dosing | Up to 96 hours following the last dose administration on Day 4 |
| Area under the plasma concentration-time curve during a dosing interval (AUCtau) | AUCtau is the area under the plasma concentration-time curve during a dosing interval | Day 1 and Day 4 |