A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: ALKS 9072, Low dose; Drug: ALKS 9072, Med dose; Drug: ALKS 9072, High dose; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30338
      • Alkermes Investigational Site
  • Illinois
    • Hoffman Estates, Illinois, United States, 60169
      • Alkermes Investigational Site
  • Missouri
    • Saint Louis, Missouri, United States, 63118
      • Alkermes Investigational Site
  • New Jersey
    • Willingboro, New Jersey, United States, 08046
      • Alkermes Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19139
      • Alkermes Investigational Site
  • Texas
    • Irving, Texas, United States, 70562
      • Alkermes Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Dosed matched placebo IM injection, given monthly
Experimental: ALKS 9072, Low dose	Drug: ALKS 9072, Low dose; IM injection, given monthly
Experimental: ALKS 9072, Med dose	Drug: ALKS 9072, Med dose; IM injection, given monthly
Experimental: ALKS 9072, High dose	Drug: ALKS 9072, High dose; IM injection, given monthly

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Alkermes, Inc.

Publications and helpful links

General Publications

• Hard ML, Mills RJ, Sadler BM, Turncliff RZ, Citrome L. Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia. J Clin Psychopharmacol. 2017 Jun;37(3):289-295. doi: 10.1097/JCP.0000000000000691.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: December 12, 2011
• First Submitted That Met QC Criteria: December 14, 2011
• First Posted (Estimate): December 16, 2011

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: ALK9072-002