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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02320032
Recruitment Status : Completed
First Posted : December 19, 2014
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Brief Summary:
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of various doses and dosing intervals of aripiprazole lauroxil.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Aripiprazole Lauroxil Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Aripiprazole Lauroxil - A
Intramuscular (IM) injection Dose and Dosing Sequence A
Drug: Aripiprazole Lauroxil
Gluteal IM injection, given once every 4 to 8 weeks

Experimental: Aripiprazole Lauroxil - B
Intramuscular (IM) injection Dose and Dosing Sequence B
Drug: Aripiprazole Lauroxil
Gluteal IM injection, given once every 4 to 8 weeks

Experimental: Aripiprazole Lauroxil - C
Intramuscular (IM) injection Dose and Dosing Sequence C
Drug: Aripiprazole Lauroxil
Gluteal IM injection, given once every 4 to 8 weeks

Experimental: Aripiprazole Lauroxil - D
Intramuscular (IM) injection Dose and Dosing Sequence D
Drug: Aripiprazole Lauroxil
Gluteal IM injection, given once every 4 to 8 weeks




Primary Outcome Measures :
  1. AUC 0-last [ Time Frame: Up to 45 weeks ]
    Area under the plasma-concentration time curve from time zero to the last quantifiable plasma concentration

  2. C max [ Time Frame: Up to 45 weeks ]
    Maximum plasma concentration

  3. T max [ Time Frame: Up to 45 weeks ]
    Time to maximum plasma concentration


Secondary Outcome Measures :
  1. AUC 0-tau [ Time Frame: Up to 45 weeks ]
    Area under the plasma-concentration time curve over the dose interval

  2. Safety and tolerability will be measured by incidence of adverse events [ Time Frame: Up to 45 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02320032


Locations
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United States, Arkansas
Alkermes Investigational Site
Little Rock, Arkansas, United States, 72211
United States, California
Alkermes Investigational Site
Cerritos, California, United States, 90703
Alkermes Investigational Site
Garden Grove, California, United States, 92845
United States, District of Columbia
Alkermes Investigational Site
Washington, District of Columbia, United States, 20016
United States, Florida
Alkermes Investigational Site
Lauderhill, Florida, United States, 33161
Alkermes Investigational Site
Leesburg, Florida, United States, 34748
Alkermes Investigational Site
Maitland, Florida, United States, 32751
Alkermes Investigational Site
Oakland Park, Florida, United States, 33334
Alkermes Investigational Site
Tampa, Florida, United States, 33613
United States, Georgia
Alkermes Investigational Site
Atlanta, Georgia, United States, 30308
United States, Illinois
Alkermes Investigational Site
Chicago, Illinois, United States, 60640
Alkermes Investigational Site
Hoffman Estates, Illinois, United States, 60169
United States, Missouri
Alkermes Investigational Site
Saint Louis, Missouri, United States, 63118
United States, New Jersey
Alkermes Investigational Site
Marlton, New Jersey, United States, 8053
United States, Texas
Alkermes Investigational Site
Austin, Texas, United States, 78754
Alkermes Investigational Site
Dallas, Texas, United States, 75243
Sponsors and Collaborators
Alkermes, Inc.
Investigators
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Study Director: Alkermes Medical Director, MD Alkermes, Inc.
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT02320032    
Other Study ID Numbers: ALK9072-A105
First Posted: December 19, 2014    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Keywords provided by Alkermes, Inc.:
Alkermes
Schizophrenia
Aripiprazole
Aripiprazole lauroxil
ALKS 9072
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole
Aripiprazole lauroxil
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists