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OpenTrials
Completed

NCT Number: NCT02320032

An Open-Label Study 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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Alkermes Investigational Site, Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aripiprazole Lauroxil

Drug

Gluteal IM injection, given once every 4 to 8 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 19, 2014
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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