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

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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)

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

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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