Clinical trial NCT01493726: A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-16
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Three active treatment groups and a placebo group are planned. Randomization will be sequential by dose level across the sites with placebo assignments randomly inserted. Each subject's participation will be approximately 8 months, including screening, treatment period, and a 3-month follow-up period.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Maximum concentration in plasma following last dose
timeFrame: 4 months
measure: Time to maximum concentration in plasma following last dose
timeFrame: 4 months
measure: Area under the plasma concentration time curve over the last dosing interval
timeFrame: 4 months
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 4 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Hoffman Estates
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Saint Louis
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Willingboro
country: United States
facility: Alkermes Investigational Site
state: New Jersey
city: Philadelphia
country: United States
facility: Alkermes Investigational Site
state: Pennsylvania
city: Irving
country: United States
facility: Alkermes Investigational Site
state: Texas
Study officials:
affiliation: Alkermes, Inc.
name: Alkermes Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: 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.