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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02636842
• Other study ID #: ALK9072-A106
• Status: Completed
• Phase: Phase 1
• First received: December 18, 2015
• Last updated: July 13, 2016
• Start date: December 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• Aripiprazole Lauroxil
Intramuscular (IM) injection, single dose

Locations

Country	Name	City	State
United States	Alkermes Investigational Site	Cerritos	California
United States	Alkermes Investigative Site	Dallas	Texas
United States	Alkermes Investigational Site	Hoffman Estates	Illinois
United States	Alkermes Investigational Site	Lemon Grove	California
United States	Alkermes Investigational Site	Marlton	New Jersey
United States	Alkermes Investigational Site	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax)		Up to 7 days	No
Secondary	Time to Cmax (Tmax)		Up to 7 days	No
Secondary	Area under the concentration-time curve from time zero to the last quantifiable time interval (AUCl0-last)		Up to 7 days	No
Secondary	Area under the concentration-time curve from time zero to time t (AUC0-t)		Up to 7 days	No
Secondary	Terminal elimination half-life (t½)		Up to 7 days	No
Secondary	Safety will be determined by incidence of adverse events		Up to 7 days	Yes