A Phase 1 Safety Study in Adults With Schizophrenia

Study Overview
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Brief Summary
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This study will determine the safety, tolerability, and pharmacokinetics (PK) of olanzapine and samidorphan in adults with schizophrenia following 14 consecutive days of oral administration of ALKS 3831.

Official Title
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A Multiple-dose, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALKS 3831 in Adult Subjects With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: ALKS 3831


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has a body mass index (BMI) of 18.0-35.0 kg/m^2, inclusive Has a primary diagnosis of schizophrenia Capable of understanding and complying with the procedures, requirements, and restrictions of the protocol. Appropriate for outpatient treatment Agrees to abide by the contraception requirements specified in the protocol for the duration of the study or is surgically sterile Willing and able to provide government-issued identification Is in good physical health Agrees to maintain normal tobacco use as well as normal activities/exercise throughout the study Additional criteria may apply Exclusion Criteria: Is currently pregnant or breastfeeding Initiated first antipsychotic treatment within the past 12 months, or <1 year has elapsed since the initial onset of active-phase schizophrenia symptoms Poses a current suicide risk at Visits 1 or 2 Has a history of poor or inadequate response to treatment with olanzapine Has used a long-acting injectable antipsychotic medication in the last 6 months with the exception of 3-month paliperidone, which must not have been received within the past 12 months. Requires or has had electroconvulsive therapy (ECT) treatment in the 6-month period prior to Visit 1 Has a diagnosis of alcohol or drug use disorder (with the exception of nicotine) Has taken opioid agonists (codeine, oxycodone, tramadol, or morphine) within the 14 days prior to Visit 1 and/or anticipates a need to take opioid medication during the study period. Has taken opioid antagonists including naltrexone (any formulations) and naloxone within 60 days prior to Visit 1, or has used any extended-release formulation of an opioid antagonist within 2 months prior to screening Tests positive for amphetamines/methamphetamine, cocaine, barbiturates, opioids (codeine, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and buprenorphine), phencyclidine and benzodiazepines. Has a known or suspected intolerance, allergy or hypersensitivity to olanzapine or opioid antagonists. Additional criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Olanzapine/samidorphan 10 mg/10 mg | Drug: ALKS 3831<br>* Oral capsule, daily administration<br>|
| Experimental: Group 2<br>Olanzapine/samidorphan 20 mg/10 mg | Drug: ALKS 3831<br>* Oral capsule, daily administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) |  | Up to 15 days of dosing | 
| Area under the concentration vs time curve over the 24 hour dosing interval (AUC0-24h) |  | Up to 15 days of dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be determined by incidence of drug-related adverse events |  | Up to 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Alkermes, ALK 3831, Samidorphan