A Phase 1 Safety Study in Adults With Schizophrenia

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkermes, Inc.

Criteria

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