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OpenTrials
Completed

NCT Number: NCT02636842

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

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

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder 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, Cerritos, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Aripiprazole Lauroxil

Drug

Intramuscular (IM) injection, single dose

Other names: ARISTADA TM

Primary outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: Up to 7 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 22, 2015
Registry last updated
Jul 14, 2016

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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