An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia
A Phase 1, Randomized, Open-Label Study Evaluating the Pharmacokinetics of Various Dosing Regimens of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia
1 other identifier
interventional
140
1 country
16
Brief Summary
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of various doses and dosing intervals of aripiprazole lauroxil.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 schizophrenia
Started Dec 2014
Typical duration for phase_1 schizophrenia
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 16, 2014
CompletedFirst Posted
Study publicly available on registry
December 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedAugust 29, 2018
August 1, 2018
1.3 years
December 16, 2014
August 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
AUC 0-last
Area under the plasma-concentration time curve from time zero to the last quantifiable plasma concentration
Up to 45 weeks
C max
Maximum plasma concentration
Up to 45 weeks
T max
Time to maximum plasma concentration
Up to 45 weeks
Secondary Outcomes (2)
AUC 0-tau
Up to 45 weeks
Safety and tolerability will be measured by incidence of adverse events
Up to 45 weeks
Study Arms (4)
Aripiprazole Lauroxil - A
EXPERIMENTALIntramuscular (IM) injection Dose and Dosing Sequence A
Aripiprazole Lauroxil - B
EXPERIMENTALIntramuscular (IM) injection Dose and Dosing Sequence B
Aripiprazole Lauroxil - C
EXPERIMENTALIntramuscular (IM) injection Dose and Dosing Sequence C
Aripiprazole Lauroxil - D
EXPERIMENTALIntramuscular (IM) injection Dose and Dosing Sequence D
Interventions
Gluteal IM injection, given once every 4 to 8 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alkermes, Inc.lead
Study Sites (16)
Alkermes Investigational Site
Little Rock, Arkansas, 72211, United States
Alkermes Investigational Site
Cerritos, California, 90703, United States
Alkermes Investigational Site
Garden Grove, California, 92845, United States
Alkermes Investigational Site
Washington D.C., District of Columbia, 20016, United States
Alkermes Investigational Site
Lauderhill, Florida, 33161, United States
Alkermes Investigational Site
Leesburg, Florida, 34748, United States
Alkermes Investigational Site
Maitland, Florida, 32751, United States
Alkermes Investigational Site
Oakland Park, Florida, 33334, United States
Alkermes Investigational Site
Tampa, Florida, 33613, United States
Alkermes Investigational Site
Atlanta, Georgia, 30308, United States
Alkermes Investigational Site
Chicago, Illinois, 60640, United States
Alkermes Investigational Site
Hoffman Estates, Illinois, 60169, United States
Alkermes Investigational Site
St Louis, Missouri, 63118, United States
Alkermes Investigational Site
Marlton, New Jersey, 8053, United States
Alkermes Investigational Site
Austin, Texas, 78754, United States
Alkermes Investigational Site
Dallas, Texas, 75243, United States
Related Publications (3)
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.0000000000000691.
PMID: 28350572RESULTWeiden PJ, Du Y, von Moltke L, Wehr A, Hard M, Marandi M, Walling DP. Pharmacokinetics, Safety, and Tolerability of a 2-Month Dose Interval Regimen of the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil: Results From a 44-Week Phase I Study. CNS Drugs. 2020 Sep;34(9):961-972. doi: 10.1007/s40263-020-00745-1.
PMID: 32621071DERIVEDHard ML, Mills RJ, Sadler BM, Wehr AY, Weiden PJ, von Moltke L. Pharmacokinetic Profile of a 2-Month Dose Regimen of Aripiprazole Lauroxil: A Phase I Study and a Population Pharmacokinetic Model. CNS Drugs. 2017 Jul;31(7):617-624. doi: 10.1007/s40263-017-0447-7.
PMID: 28597226DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alkermes Medical Director, MD
Alkermes, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2014
First Posted
December 19, 2014
Study Start
December 1, 2014
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
August 29, 2018
Record last verified: 2018-08