Schizophrenia
Conditions
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.
Interventions
IM injection, given monthly
DRUGALKS 9072, Med dose
IM injection, given monthly
IM injection, given monthly
DRUGPlacebo
Dosed matched placebo IM injection, given monthly
Sponsors
Alkermes, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events | 4 months |
Countries
United States
Outcome results
None listed