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

Alkermes

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: Aripiprazole Lauroxil

Study type: Interventional

Funder types: Industry

Identifiers

NCT02320032

ALK9072-A105

Details and patient eligibility

About

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

Enrollment: 140 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 4 patient groups

Aripiprazole Lauroxil - A

Experimental group

Description:

Intramuscular (IM) injection Dose and Dosing Sequence A

Treatment:

Drug: Aripiprazole Lauroxil

Aripiprazole Lauroxil - B

Experimental group

Description:

Intramuscular (IM) injection Dose and Dosing Sequence B

Treatment:

Drug: Aripiprazole Lauroxil

Aripiprazole Lauroxil - C

Experimental group

Description:

Intramuscular (IM) injection Dose and Dosing Sequence C

Treatment:

Drug: Aripiprazole Lauroxil

Aripiprazole Lauroxil - D

Experimental group

Description:

Intramuscular (IM) injection Dose and Dosing Sequence D

Treatment:

Drug: Aripiprazole Lauroxil