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

NCT02636842 | Completed Phase 1

• 1 other identifier: ALK9072-A106
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Schizophrenia; Schizoaffective Disorder; Aripiprazole Lauroxil; Aripiprazole; ALKS 9072; Alkermes

Outcome Measures

Primary Outcomes (1)

• Maximum plasma concentration (Cmax)

  Up to 7 days

Secondary Outcomes (5)

• Time to Cmax (Tmax)

  Up to 7 days

• Area under the concentration-time curve from time zero to the last quantifiable time interval (AUCl0-last)

  Up to 7 days

• Area under the concentration-time curve from time zero to time t (AUC0-t)

  Up to 7 days

• Terminal elimination half-life (t½)

  Up to 7 days

• Safety will be determined by incidence of adverse events

  Up to 7 days

Study Arms (1)

Location

OTHER

Deltoid or Gluteal Muscle

Drug: Aripiprazole Lauroxil

Interventions

Aripiprazole Lauroxil DRUG

Intramuscular (IM) injection, single dose

Also known as: ARISTADA TM

Location

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (6)

Alkermes Investigational Site

Cerritos, California, 90703, United States

Location

Alkermes Investigational Site

Lemon Grove, California, 91945, United States

Location

Alkermes Investigational Site

Oakland, California, 94612, United States

Location

Alkermes Investigational Site

Hoffman Estates, Illinois, 60169, United States

Location

Alkermes Investigational Site

Marlton, New Jersey, 80530, United States

Location

Alkermes Investigative Site

Dallas, Texas, 75243, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

aripiprazole lauroxil

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Robert Risinger, MD

  Alkermes, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: December 22, 2015
• Study Start: December 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 14, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)