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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02320032
• Other study ID #: ALK9072-A105
• Status: Completed
• Phase: Phase 1
• Start date: December 2014
• Est. completion date: April 2016

Study information

• Verified date: August 2018
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Aripiprazole Lauroxil
Gluteal IM injection, given once every 4 to 8 weeks

Locations

Country	Name	City	State
United States	Alkermes Investigational Site	Atlanta	Georgia
United States	Alkermes Investigational Site	Austin	Texas
United States	Alkermes Investigational Site	Cerritos	California
United States	Alkermes Investigational Site	Chicago	Illinois
United States	Alkermes Investigational Site	Dallas	Texas
United States	Alkermes Investigational Site	Garden Grove	California
United States	Alkermes Investigational Site	Hoffman Estates	Illinois
United States	Alkermes Investigational Site	Lauderhill	Florida
United States	Alkermes Investigational Site	Leesburg	Florida
United States	Alkermes Investigational Site	Little Rock	Arkansas
United States	Alkermes Investigational Site	Maitland	Florida
United States	Alkermes Investigational Site	Marlton	New Jersey
United States	Alkermes Investigational Site	Oakland Park	Florida
United States	Alkermes Investigational Site	Saint Louis	Missouri
United States	Alkermes Investigational Site	Tampa	Florida
United States	Alkermes Investigational Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hard ML, Mills RJ, Sadler BM, Turncliff RZ, Citrome L. Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia. J Clin Psychopharmacol. 2017 Jun;37(3):289-295. doi: 10.1097/JCP.000000000000 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC 0-last	Area under the plasma-concentration time curve from time zero to the last quantifiable plasma concentration	Up to 45 weeks
Primary	C max	Maximum plasma concentration	Up to 45 weeks
Primary	T max	Time to maximum plasma concentration	Up to 45 weeks
Secondary	AUC 0-tau	Area under the plasma-concentration time curve over the dose interval	Up to 45 weeks
Secondary	Safety and tolerability will be measured by incidence of adverse events		Up to 45 weeks