A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This study will determine the pharmacokinetics (PK), safety, and tolerability of ALKS 9072 (also known as ALKS 9070) after 4 monthly doses in adults with chronic stable schizophrenia.

Detailed Description
-----------------
Three active treatment groups and a placebo group are planned. Randomization will be sequential by dose level across the sites with placebo assignments randomly inserted. Each subject's participation will be approximately 8 months, including screening, treatment period, and a 3-month follow-up period.

Official Title
-----------------
A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ALKS 9072 in Subjects With Chronic Stable Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: ALKS 9072, Low dose
* Drug: ALKS 9072, Med dose
* Drug: ALKS 9072, High dose
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of chronic schizophrenia that is clinically stable Body mass index (BMI) between 18.5 and 35.0 kg/m2, inclusive Stable antipsychotic medication regimen for >/= 2 months before Screening Be willing and able to be confined to an inpatient clinical research unit for a total of 37 days during the course of the study Exclusion Criteria: Aripiprazole used within 30 days before Screening History of intolerance of or allergy or hypersensitivity to aripiprazole, its excipients, other antipsychotic agents, or INTRALIPID (including peanuts, soy, egg, or glycerol) Current diagnosis of an Axis I disorder other than schizophrenia History of seizure disorder or any condition associated with seizures History of neuroleptic malignant syndrome (NMS) Positive test result for HIV, hepatitis B surface antigen, or anti-hepatitis C antibodies Received medication by IM injection within 30 days before Screening Monoamine oxidase inhibitors (eg, phenelzine, tranylcypromine, selegiline) used within 30 days before Screening DSM-IV-TR diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence within 12 months before Screening Donation of blood or blood components within 4 weeks before Screening

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALKS 9072, Low dose<br> | Drug: ALKS 9072, Low dose<br>* IM injection, given monthly<br>|
| Experimental: ALKS 9072, Med dose<br> | Drug: ALKS 9072, Med dose<br>* IM injection, given monthly<br>|
| Experimental: ALKS 9072, High dose<br> | Drug: ALKS 9072, High dose<br>* IM injection, given monthly<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Dosed matched placebo IM injection, given monthly<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration in plasma following last dose |  | 4 months | 
| Time to maximum concentration in plasma following last dose |  | 4 months | 
| Area under the plasma concentration time curve over the last dosing interval |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events |  | 4 months |