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

Alkermes, Inc.2 sites in 1 country47 target enrollmentDecember 2015

ConditionsSchizophrenia Schizoaffective Disorder

InterventionsAripiprazole Lauroxil

DrugsAripiprazole Lauroxil

Overview

Phase: Phase 1
Intervention: Aripiprazole Lauroxil
Conditions: Schizophrenia
Sponsor: Alkermes, Inc.
Enrollment: 47
Locations: 2
Primary Endpoint: Maximum plasma concentration (Cmax)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

December 2015

End Date

June 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Alkermes, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Location

Deltoid or Gluteal Muscle

Intervention: Aripiprazole Lauroxil

Outcomes

Primary Outcomes

Maximum plasma concentration (Cmax)

Time Frame: Up to 7 days

Secondary Outcomes

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)