A Phase 1 Safety Study in Adults With Schizophrenia

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