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A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder

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: NCT02636842
Recruitment Status : Completed
First Posted : December 22, 2015
Last Update Posted : July 14, 2016
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Brief Summary:
The study will determine the safety, tolerability, and pharmacokinetics of aripiprazole lauroxil in adults with schizophrenia or schizoaffective disorder.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Location
Deltoid or Gluteal Muscle
Drug: Aripiprazole Lauroxil
Intramuscular (IM) injection, single dose
Other Name: ARISTADA TM




Primary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: Up to 7 days ]

Secondary Outcome Measures :
  1. Time to Cmax (Tmax) [ Time Frame: Up to 7 days ]
  2. Area under the concentration-time curve from time zero to the last quantifiable time interval (AUCl0-last) [ Time Frame: Up to 7 days ]
  3. Area under the concentration-time curve from time zero to time t (AUC0-t) [ Time Frame: Up to 7 days ]
  4. Terminal elimination half-life (t½) [ Time Frame: Up to 7 days ]
  5. Safety will be determined by incidence of adverse events [ Time Frame: Up to 7 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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

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): NCT02636842


Locations
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United States, California
Alkermes Investigational Site
Cerritos, California, United States, 90703
Alkermes Investigational Site
Lemon Grove, California, United States, 91945
Alkermes Investigational Site
Oakland, California, United States, 94612
United States, Illinois
Alkermes Investigational Site
Hoffman Estates, Illinois, United States, 60169
United States, New Jersey
Alkermes Investigational Site
Marlton, New Jersey, United States, 80530
United States, Texas
Alkermes Investigative Site
Dallas, Texas, United States, 75243
Sponsors and Collaborators
Alkermes, Inc.
Investigators
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Study Director: Robert Risinger, MD Alkermes, Inc.
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Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT02636842    
Other Study ID Numbers: ALK9072-A106
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Alkermes, Inc.:
Schizophrenia
Schizoaffective Disorder
Aripiprazole Lauroxil
Aripiprazole
ALKS 9072
Alkermes
Additional relevant MeSH terms:
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Disease
Schizophrenia
Psychotic Disorders
Pathologic Processes
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