Back to resultsA Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder
Primary Purpose
Schizophrenia, Schizoaffective Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole Lauroxil
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Schizoaffective Disorder, Aripiprazole Lauroxil, Aripiprazole, ALKS 9072, Alkermes
Eligibility Criteria
Inclusion Criteria:
- Has a diagnosis of chronic schizophrenia or schizoaffective disorder
- Has demonstrated ability to tolerate aripiprazole
- Has been on a stable antipsychotic medication regimen without any changes for at least 2 months prior to screening
- Has a body mass index (BMI) of 18.0 to 40.0 kg/m2, inclusive
- Additional criteria may apply
Exclusion Criteria:
- Is pregnant, is planning to become pregnant, or is currently breastfeeding
- Has received aripiprazole lauroxil or IM depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months or currently treated with clozapine
- Is a danger to himself/herself at screening or upon admission
- Has a history of or positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Has a positive urine drug screen at screening or Day 1
- Additional criteria may apply
Sites / Locations
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigative Site
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Location
Arm Description
Deltoid or Gluteal Muscle
Outcomes
Primary Outcome Measures
Maximum plasma concentration (Cmax)
Secondary Outcome Measures
Time to Cmax (Tmax)
Area under the concentration-time curve from time zero to the last quantifiable time interval (AUCl0-last)
Area under the concentration-time curve from time zero to time t (AUC0-t)
Terminal elimination half-life (t½)
Safety will be determined by incidence of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02636842
Brief Title
A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder
Official Title
A Phase 1, Randomized, Open-label, Single Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aripiprazole Lauroxil Following Administration to the Deltoid or Gluteal Muscle in Adults With Schizophrenia or Schizoaffective Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (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
The study will determine the safety, tolerability, and pharmacokinetics of aripiprazole lauroxil in adults with schizophrenia or schizoaffective disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Schizophrenia, Schizoaffective Disorder, Aripiprazole Lauroxil, Aripiprazole, ALKS 9072, Alkermes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Location
Arm Type
Other
Arm Description
Deltoid or Gluteal Muscle
Intervention Type
Drug
Intervention Name(s)
Aripiprazole Lauroxil
Other Intervention Name(s)
ARISTADA TM
Intervention Description
Intramuscular (IM) injection, single dose
Primary Outcome Measure Information:
Title
Maximum plasma concentration (Cmax)
Time Frame
Up to 7 days
Secondary Outcome Measure Information:
Title
Time to Cmax (Tmax)
Time Frame
Up to 7 days
Title
Area under the concentration-time curve from time zero to the last quantifiable time interval (AUCl0-last)
Time Frame
Up to 7 days
Title
Area under the concentration-time curve from time zero to time t (AUC0-t)
Time Frame
Up to 7 days
Title
Terminal elimination half-life (t½)
Time Frame
Up to 7 days
Title
Safety will be determined by incidence of adverse events
Time Frame
Up to 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has a diagnosis of chronic schizophrenia or schizoaffective disorder
Has demonstrated ability to tolerate aripiprazole
Has been on a stable antipsychotic medication regimen without any changes for at least 2 months prior to screening
Has a body mass index (BMI) of 18.0 to 40.0 kg/m2, inclusive
Additional criteria may apply
Exclusion Criteria:
Is pregnant, is planning to become pregnant, or is currently breastfeeding
Has received aripiprazole lauroxil or IM depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months or currently treated with clozapine
Is a danger to himself/herself at screening or upon admission
Has a history of or positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
Has a positive urine drug screen at screening or Day 1
Additional criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Risinger, MD
Organizational Affiliation
Alkermes, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Alkermes Investigational Site
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Alkermes Investigational Site
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
Alkermes Investigational Site
City
Oakland
State/Province
California
ZIP/Postal Code
94612
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
Marlton
State/Province
New Jersey
ZIP/Postal Code
80530
Country
United States
Facility Name
Alkermes Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder
We'll reach out to this number within 24 hrs