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An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole Lauroxil
Sponsored by
Alkermes, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Alkermes, Schizophrenia, Aripiprazole, Aripiprazole lauroxil, ALKS 9072

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has stable 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 35.0 kg/m2, inclusive
  • Additional criteria may apply

Exclusion Criteria:

  • Is pregnant, breastfeeding, or is planning to become pregnant during the study period
  • Has received aripiprazole lauroxil or IM depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months
  • 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 Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • 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

Experimental

Arm Label

Aripiprazole Lauroxil - A

Aripiprazole Lauroxil - B

Aripiprazole Lauroxil - C

Aripiprazole Lauroxil - D

Arm Description

Intramuscular (IM) injection Dose and Dosing Sequence A

Intramuscular (IM) injection Dose and Dosing Sequence B

Intramuscular (IM) injection Dose and Dosing Sequence C

Intramuscular (IM) injection Dose and Dosing Sequence D

Outcomes

Primary Outcome Measures

AUC 0-last
Area under the plasma-concentration time curve from time zero to the last quantifiable plasma concentration
C max
Maximum plasma concentration
T max
Time to maximum plasma concentration

Secondary Outcome Measures

AUC 0-tau
Area under the plasma-concentration time curve over the dose interval
Safety and tolerability will be measured by incidence of adverse events

Full Information

First Posted
December 16, 2014
Last Updated
August 28, 2018
Sponsor
Alkermes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02320032
Brief Title
An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia
Official Title
A Phase 1, Randomized, Open-Label Study Evaluating the Pharmacokinetics of Various Dosing Regimens of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 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
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of various doses and dosing intervals of aripiprazole lauroxil.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Alkermes, Schizophrenia, Aripiprazole, Aripiprazole lauroxil, ALKS 9072

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aripiprazole Lauroxil - A
Arm Type
Experimental
Arm Description
Intramuscular (IM) injection Dose and Dosing Sequence A
Arm Title
Aripiprazole Lauroxil - B
Arm Type
Experimental
Arm Description
Intramuscular (IM) injection Dose and Dosing Sequence B
Arm Title
Aripiprazole Lauroxil - C
Arm Type
Experimental
Arm Description
Intramuscular (IM) injection Dose and Dosing Sequence C
Arm Title
Aripiprazole Lauroxil - D
Arm Type
Experimental
Arm Description
Intramuscular (IM) injection Dose and Dosing Sequence D
Intervention Type
Drug
Intervention Name(s)
Aripiprazole Lauroxil
Intervention Description
Gluteal IM injection, given once every 4 to 8 weeks
Primary Outcome Measure Information:
Title
AUC 0-last
Description
Area under the plasma-concentration time curve from time zero to the last quantifiable plasma concentration
Time Frame
Up to 45 weeks
Title
C max
Description
Maximum plasma concentration
Time Frame
Up to 45 weeks
Title
T max
Description
Time to maximum plasma concentration
Time Frame
Up to 45 weeks
Secondary Outcome Measure Information:
Title
AUC 0-tau
Description
Area under the plasma-concentration time curve over the dose interval
Time Frame
Up to 45 weeks
Title
Safety and tolerability will be measured by incidence of adverse events
Time Frame
Up to 45 weeks

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 stable 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 35.0 kg/m2, inclusive Additional criteria may apply Exclusion Criteria: Is pregnant, breastfeeding, or is planning to become pregnant during the study period Has received aripiprazole lauroxil or IM depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months 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
Alkermes Medical Director, MD
Organizational Affiliation
Alkermes, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Alkermes Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Alkermes Investigational Site
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Alkermes Investigational Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Alkermes Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Alkermes Investigational Site
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Alkermes Investigational Site
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Alkermes Investigational Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Alkermes Investigational Site
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Alkermes Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Alkermes Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Alkermes Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
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
Marlton
State/Province
New Jersey
ZIP/Postal Code
8053
Country
United States
Facility Name
Alkermes Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
Alkermes Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
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
result
PubMed Identifier
32621071
Citation
Weiden PJ, Du Y, von Moltke L, Wehr A, Hard M, Marandi M, Walling DP. Pharmacokinetics, Safety, and Tolerability of a 2-Month Dose Interval Regimen of the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil: Results From a 44-Week Phase I Study. CNS Drugs. 2020 Sep;34(9):961-972. doi: 10.1007/s40263-020-00745-1.
Results Reference
derived
PubMed Identifier
28597226
Citation
Hard ML, Mills RJ, Sadler BM, Wehr AY, Weiden PJ, von Moltke L. Pharmacokinetic Profile of a 2-Month Dose Regimen of Aripiprazole Lauroxil: A Phase I Study and a Population Pharmacokinetic Model. CNS Drugs. 2017 Jul;31(7):617-624. doi: 10.1007/s40263-017-0447-7.
Results Reference
derived

Learn more about this trial

An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia

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