Phase 1 ALKS 1140 in Healthy Adults

Study Overview
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Brief Summary
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To evaluate the safety and tolerability of ALKS 1140 in healthy adult subjects

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Escalating Doses of ALKS 1140 With a Pilot Evaluation of Food Effect in Healthy Adult Subjects

Conditions
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Central Nervous System Diseases

Intervention / Treatment
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* Drug: Placebo
* Drug: ALKS 1140


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) ≥18 and <30 kg/m2 Exclusion Criteria: Clinically significant illness or disease including significant cardiac, gastrointestinal (stomach) Subjects who have known allergic reactions to food or medications Women of childbearing potential Any clinically significant lifetime history of suicidal behavior or ideation (thoughts) Subject had lymphoma, leukemia, or any malignancy within the past 5 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo administered orally | Drug: Placebo<br>* Oral matching placebo<br>|
| Active Comparator: ALKS 1140<br>Up to 8 single ascending doses of ALKS 1140 and 4 multiple ascending doses administered orally | Drug: ALKS 1140<br>* Active oral dose of ALKS 1140<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |