A Phase 1 Safety Study in Adults With Schizophrenia

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: ALKS 3831

• 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

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-17
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-21
• Last Update Posted: 2016-09-22

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