A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: ALKS 9072, Med dose; Drug: Placebo; Drug: ALKS 9072, Low dose; Drug: ALKS 9072, High dose

• Registration Number: NCT01493726
• Lead Sponsor: Alkermes, Inc.

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2011-12-14
• Study First Posted: 2011-12-16
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALKS 9072, Med dose	ALKS 9072, Med dose	-
Placebo	Placebo	-
ALKS 9072, Low dose	ALKS 9072, Low dose	-
ALKS 9072, High dose	ALKS 9072, High dose	-

Primary Outcome Measures

Name	Time	Method
Maximum concentration in plasma following last dose	4 months
Area under the plasma concentration time curve over the last dosing interval	4 months
Time to maximum concentration in plasma following last dose	4 months

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	4 months

Trial Locations

Locations (1)

Alkermes Investigational Site; 🇺🇸 Irving, Texas, United States