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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005012-15 | EudraCT Number |
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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 male adults
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AC-083, Single Ascending Dose | Experimental | AC-083 administered at different single dose levels in a sequential manner, and in a maximum of 9 dose levels starting from 1 mg (number of cohorts and dose levels will depend on the safety and pharmacokinetic results of the previous cohort). Each dose level will be investigated in a new group of 8 healthy male subjects (6 on active drug and 2 on placebo) |
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| Placebo, Single Ascending Dose | Placebo Comparator | Matched placebo administered as single ascending doses in parallel to AC-083 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC-083 | Drug | Hard gelatin capsules for oral administration formulated at a strengths of 1, 10 and 100 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Treatment-emergent AEs and treatment emergent serious AEs | From baseline to end of study (EOS) (up to Day 12) |
| Changes from baseline in supine blood pressure | Supine blood pressure (mmHg) | From baseline to EOS (up to Day 12) |
| Changes from baseline in electrocardiogram (ECG) variables | ECG variables are to be recorded at rest using a standard 12-lead ECG | From baseline to EOS (up to Day 12) |
| Changes from baseline in pulse rate | Pulse rate (bpm) | From baseline to EOS (up to Day 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) following single oral ascending doses | Cmax is derived from the observed plasma concentration-time curves | From pre-dose on Day 1 to up to Day 12 |
| Time to reach Cmax (tmax) following single oral ascending doses |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site | Berlin | 14050 | Germany |
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| Placebo | Drug | Placebo capsules matching AC-083 capsules |
|
Tmax is derived from the observed plasma concentration-time curves
| From pre-dose on Day 1 to up to Day 12 |
| Terminal half-life [t(1/2)] following single oral ascending doses | From pre-dose on Day 1 to up to Day 12 |
| Area under the plasma concentration-time curve (AUC) following single oral ascending doses | AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification, from zero to infinity and from zero to 24 h after study drug administration | From pre-dose on Day 1 to up to Day 12 |