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

Sponsor

Alkermes, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02636842

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

7.8

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizoaffective Disorder	Drug: Aripiprazole Lauroxil	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Location Deltoid or Gluteal Muscle	Drug: Aripiprazole Lauroxil Intramuscular (IM) injection, single dose Other Names: ARISTADA TM

Arm

Intervention/Treatment

Other: Location

Deltoid or Gluteal Muscle

Drug: Aripiprazole Lauroxil

Intramuscular (IM) injection, single dose

Other Names:

ARISTADA TM

Outcome Measures

Primary Outcome Measures

Maximum plasma concentration (Cmax) [Up to 7 days]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alkermes Investigational Site	Cerritos	California	United States	90703
2	Alkermes Investigational Site	Lemon Grove	California	United States	91945
3	Alkermes Investigational Site	Oakland	California	United States	94612
4	Alkermes Investigational Site	Hoffman Estates	Illinois	United States	60169
5	Alkermes Investigational Site	Marlton	New Jersey	United States	80530
6	Alkermes Investigative Site	Dallas	Texas	United States	75243