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

A Phase 1, Randomized, Open-Label Study Evaluating the Pharmacokinetics of Various Dosing Regimens of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Aripiprazole Lauroxil

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Alkermes Investigational Site
  • California
    • Cerritos, California, United States, 90703
      • Alkermes Investigational Site
    • Garden Grove, California, United States, 92845
      • Alkermes Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Alkermes Investigational Site
  • Florida
    • 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
      • Alkermes Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Alkermes Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Alkermes Investigational Site
    • Hoffman Estates, Illinois, United States, 60169
      • Alkermes Investigational Site
  • Missouri
    • Saint Louis, Missouri, United States, 63118
      • Alkermes Investigational Site
  • New Jersey
    • Marlton, New Jersey, United States, 8053
      • Alkermes Investigational Site
  • Texas
    • Austin, Texas, United States, 78754
      • Alkermes Investigational Site
    • Dallas, Texas, United States, 75243
      • Alkermes Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC 0-last	Area under the plasma-concentration time curve from time zero to the last quantifiable plasma concentration	Up to 45 weeks
C max	Maximum plasma concentration	Up to 45 weeks
T max	Time to maximum plasma concentration	Up to 45 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC 0-tau	Area under the plasma-concentration time curve over the dose interval	Up to 45 weeks
Safety and tolerability will be measured by incidence of adverse events		Up to 45 weeks

Collaborators and Investigators

• Sponsor: Alkermes, Inc.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ACTUAL): April 1, 2016
• Study Completion (ACTUAL): April 1, 2016

Study Registration Dates

• First Submitted: December 16, 2014
• First Submitted That Met QC Criteria: December 16, 2014
• First Posted (ESTIMATE): December 19, 2014

Study Record Updates

• Last Update Posted (ACTUAL): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Schizophrenia; Aripiprazole; Alkermes; ALKS 9072; Aripiprazole lauroxil
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole; Aripiprazole lauroxil
• Other Study ID Numbers: ALK9072-A105