A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia
A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ALKS 9072 in Subjects With Chronic Stable Schizophrenia
1 other identifier
interventional
88
1 country
6
Brief Summary
This study will determine the pharmacokinetics (PK), safety, and tolerability of ALKS 9072 (also known as ALKS 9070) after 4 monthly doses in adults with chronic stable schizophrenia.
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 2011
Typical duration for phase_1 schizophrenia
6 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, 2011
CompletedFirst Submitted
Initial submission to the registry
December 12, 2011
CompletedFirst Posted
Study publicly available on registry
December 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedAugust 29, 2018
August 1, 2018
1.5 years
December 12, 2011
August 28, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Maximum concentration in plasma following last dose
4 months
Time to maximum concentration in plasma following last dose
4 months
Area under the plasma concentration time curve over the last dosing interval
4 months
Secondary Outcomes (1)
Number of Participants with Adverse Events
4 months
Study Arms (4)
ALKS 9072, Low dose
EXPERIMENTALALKS 9072, Med dose
EXPERIMENTALALKS 9072, High dose
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of chronic schizophrenia that is clinically stable
- Body mass index (BMI) between 18.5 and 35.0 kg/m2, inclusive
- Stable antipsychotic medication regimen for \>/= 2 months before Screening
- Be willing and able to be confined to an inpatient clinical research unit for a total of 37 days during the course of the study
You may not qualify if:
- Aripiprazole used within 30 days before Screening
- History of intolerance of or allergy or hypersensitivity to aripiprazole, its excipients, other antipsychotic agents, or INTRALIPID (including peanuts, soy, egg, or glycerol)
- Current diagnosis of an Axis I disorder other than schizophrenia
- History of seizure disorder or any condition associated with seizures
- History of neuroleptic malignant syndrome (NMS)
- Positive test result for HIV, hepatitis B surface antigen, or anti-hepatitis C antibodies
- Received medication by IM injection within 30 days before Screening
- Monoamine oxidase inhibitors (eg, phenelzine, tranylcypromine, selegiline) used within 30 days before Screening
- DSM-IV-TR diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence within 12 months before Screening
- Donation of blood or blood components within 4 weeks before Screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alkermes, Inc.lead
Study Sites (6)
Alkermes Investigational Site
Atlanta, Georgia, 30338, United States
Alkermes Investigational Site
Hoffman Estates, Illinois, 60169, United States
Alkermes Investigational Site
St Louis, Missouri, 63118, United States
Alkermes Investigational Site
Willingboro, New Jersey, 08046, United States
Alkermes Investigational Site
Philadelphia, Pennsylvania, 19139, United States
Alkermes Investigational Site
Irving, Texas, 70562, United States
Related 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.0000000000000691.
PMID: 28350572RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alkermes Medical Director, MD
Alkermes, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2011
First Posted
December 16, 2011
Study Start
December 1, 2011
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
August 29, 2018
Record last verified: 2018-08