A Phase 1 Safety Study in Adults With Schizophrenia
- Registration Number
- NCT02804568
- Lead Sponsor
- Alkermes, Inc.
- Brief Summary
This study will determine the safety, tolerability, and pharmacokinetics (PK) of olanzapine and samidorphan in adults with schizophrenia following 14 consecutive days of oral administration of ALKS 3831.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
- Has a body mass index (BMI) of 18.0-35.0 kg/m^2, inclusive
- Has a primary diagnosis of schizophrenia
- Capable of understanding and complying with the procedures, requirements, and restrictions of the protocol.
- Appropriate for outpatient treatment
- Agrees to abide by the contraception requirements specified in the protocol for the duration of the study or is surgically sterile
- Willing and able to provide government-issued identification
- Is in good physical health
- Agrees to maintain normal tobacco use as well as normal activities/exercise throughout the study
- Additional criteria may apply
Exclusion Criteria
- Is currently pregnant or breastfeeding
- Initiated first antipsychotic treatment within the past 12 months, or <1 year has elapsed since the initial onset of active-phase schizophrenia symptoms
- Poses a current suicide risk at Visits 1 or 2
- Has a history of poor or inadequate response to treatment with olanzapine
- Has used a long-acting injectable antipsychotic medication in the last 6 months with the exception of 3-month paliperidone, which must not have been received within the past 12 months.
- Requires or has had electroconvulsive therapy (ECT) treatment in the 6-month period prior to Visit 1
- Has a diagnosis of alcohol or drug use disorder (with the exception of nicotine)
- Has taken opioid agonists (codeine, oxycodone, tramadol, or morphine) within the 14 days prior to Visit 1 and/or anticipates a need to take opioid medication during the study period.
- Has taken opioid antagonists including naltrexone (any formulations) and naloxone within 60 days prior to Visit 1, or has used any extended-release formulation of an opioid antagonist within 2 months prior to screening
- Tests positive for amphetamines/methamphetamine, cocaine, barbiturates, opioids (codeine, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and buprenorphine), phencyclidine and benzodiazepines.
- Has a known or suspected intolerance, allergy or hypersensitivity to olanzapine or opioid antagonists.
- Additional criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 ALKS 3831 Olanzapine/samidorphan 10 mg/10 mg Group 2 ALKS 3831 Olanzapine/samidorphan 20 mg/10 mg
- Primary Outcome Measures
Name Time Method Maximum plasma concentration (Cmax) Up to 15 days of dosing Area under the concentration vs time curve over the 24 hour dosing interval (AUC0-24h) Up to 15 days of dosing
- Secondary Outcome Measures
Name Time Method Safety will be determined by incidence of drug-related adverse events Up to 21 days
Trial Locations
- Locations (1)
Alkermes Investigational Site
🇺🇸Dayton, Ohio, United States