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

Alkermes

Status and phase: Completed; Phase 1

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Drug: Aripiprazole Lauroxil

Study type: Interventional

Funder types: Industry

Identifiers

NCT02636842

ALK9072-A106

Details and patient eligibility

About

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

Enrollment: 47 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

Location

Other group

Description:

Deltoid or Gluteal Muscle

Treatment:

Drug: Aripiprazole Lauroxil