Back to resultsA Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ALKS 9072, Low dose
ALKS 9072, Med dose
ALKS 9072, High dose
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
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
Sites / Locations
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
ALKS 9072, Low dose
ALKS 9072, Med dose
ALKS 9072, High dose
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Maximum concentration in plasma following last dose
Time to maximum concentration in plasma following last dose
Area under the plasma concentration time curve over the last dosing interval
Secondary Outcome Measures
Number of Participants with Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01493726
Brief Title
A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alkermes, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ALKS 9072, Low dose
Arm Type
Experimental
Arm Title
ALKS 9072, Med dose
Arm Type
Experimental
Arm Title
ALKS 9072, High dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ALKS 9072, Low dose
Intervention Description
IM injection, given monthly
Intervention Type
Drug
Intervention Name(s)
ALKS 9072, Med dose
Intervention Description
IM injection, given monthly
Intervention Type
Drug
Intervention Name(s)
ALKS 9072, High dose
Intervention Description
IM injection, given monthly
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dosed matched placebo IM injection, given monthly
Primary Outcome Measure Information:
Title
Maximum concentration in plasma following last dose
Time Frame
4 months
Title
Time to maximum concentration in plasma following last dose
Time Frame
4 months
Title
Area under the plasma concentration time curve over the last dosing interval
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alkermes Medical Director, MD
Organizational Affiliation
Alkermes, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Alkermes Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Alkermes Investigational Site
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Alkermes Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
Facility Name
Alkermes Investigational Site
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
Alkermes Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Alkermes Investigational Site
City
Irving
State/Province
Texas
ZIP/Postal Code
70562
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28350572
Citation
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.
Results Reference
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A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia
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