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

Sponsor

Alkermes, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02320032

Collaborator

(none)

140

Enrollment

Locations

Arms

Duration (Months)

8.8

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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

Study Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alkermes Investigational Site	Little Rock	Arkansas	United States	72211
2	Alkermes Investigational Site	Cerritos	California	United States	90703
3	Alkermes Investigational Site	Garden Grove	California	United States	92845
4	Alkermes Investigational Site	Washington	District of Columbia	United States	20016
5	Alkermes Investigational Site	Lauderhill	Florida	United States	33161
6	Alkermes Investigational Site	Leesburg	Florida	United States	34748
7	Alkermes Investigational Site	Maitland	Florida	United States	32751
8	Alkermes Investigational Site	Oakland Park	Florida	United States	33334
9	Alkermes Investigational Site	Tampa	Florida	United States	33613
10	Alkermes Investigational Site	Atlanta	Georgia	United States	30308
11	Alkermes Investigational Site	Chicago	Illinois	United States	60640
12	Alkermes Investigational Site	Hoffman Estates	Illinois	United States	60169
13	Alkermes Investigational Site	Saint Louis	Missouri	United States	63118
14	Alkermes Investigational Site	Marlton	New Jersey	United States	8053
15	Alkermes Investigational Site	Austin	Texas	United States	78754
16	Alkermes Investigational Site	Dallas	Texas	United States	75243