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Sponsor Decision
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To evaluate the safety and tolerability of ALKS 1140 in healthy adult subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo administered orally |
|
| ALKS 1140 | Active Comparator | Up to 8 single ascending doses of ALKS 1140 and 4 multiple ascending doses administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Oral matching placebo |
| |
| ALKS 1140 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events | Up to 28 days | |
| Change in Columbia-Suicide Severity Rating Scale (C-SSRS) | Change in C-SSRS measured in Multiple-Ascending Dose subjects only | Up to 28 days |
| 12-lead safety ECG results | ECG parameters (Heart Rate, RR, PR, QRS, QT, QTcF, T wave) will be analysed using descriptive summary statistics (mean, standard deviation, median, minimum, and maximum for continuous variables) and as a change from baseline by dose level and treatment group. For the QT interval assessment, clinically abnormal ECG results for QTcF will be tabulated by protocol-specified millisecond range categories by dose and treatment group. Potentially clinically significant findings will be summarized by dose and treatment group. | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) for ALKS 1140 | Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29 | |
| Time to Cmax (Tmax) | Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Clinical Investigative Site | Brisbane | Australia |
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| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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| Drug |
Active oral dose of ALKS 1140 |
|
| Half-life (t1/2) of ALKS 1140 | Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours |
| Time until first quantifiable concentration (tlag) | Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29 |
| Area under the concentration-time curve (AUC) | Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29 |
| Apparent volume of distribution at terminal phase (Vz/F) | Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29 |
| Apparent total clearance following oral administration (CL/F) | Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29 |
| Change from baseline in QTcF (Fridericia method) interval in response to treatment (Holter monitoring) | Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29 |
| Accumulation Index (RA) | Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29 |