Clinical trial NCT02636842: A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
Schizoaffective Disorder
Aripiprazole Lauroxil
Aripiprazole
ALKS 9072
Alkermes
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2015-12-22
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: Up to 7 days
Secondary outcomes:
measure: Time to Cmax (Tmax)
timeFrame: Up to 7 days
measure: Area under the concentration-time curve from time zero to the last quantifiable time interval (AUCl0-last)
timeFrame: Up to 7 days
measure: Area under the concentration-time curve from time zero to time t (AUC0-t)
timeFrame: Up to 7 days
measure: Terminal elimination half-life (t½)
timeFrame: Up to 7 days
measure: Safety will be determined by incidence of adverse events
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Cerritos
country: United States
facility: Alkermes Investigational Site
state: California
city: Lemon Grove
country: United States
facility: Alkermes Investigational Site
state: California
city: Oakland
country: United States
facility: Alkermes Investigational Site
state: California
city: Hoffman Estates
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Marlton
country: United States
facility: Alkermes Investigational Site
state: New Jersey
city: Dallas
country: United States
facility: Alkermes Investigative Site
state: Texas
Study officials:
affiliation: Alkermes, Inc.
name: Robert Risinger, MD
role: STUDY_DIRECTOR
References: