A Phase 1 Safety Study in Adults With Schizophrenia

A Multiple-dose, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALKS 3831 in Adult Subjects With Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: ALKS 3831

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Alkermes Investigational Site
  • New Jersey
    • Clementon, New Jersey, United States, 08021
      • Alkermes Investigational Site
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Alkermes Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1; Olanzapine/samidorphan 10 mg/10 mg	Drug: ALKS 3831; Oral capsule, daily administration
EXPERIMENTAL: Group 2; Olanzapine/samidorphan 20 mg/10 mg	Drug: ALKS 3831; Oral capsule, daily administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Safety will be determined by incidence of drug-related adverse events	Up to 21 days

Collaborators and Investigators

• Sponsor: Alkermes, Inc.

Publications and helpful links

General Publications

• Sun L, McDonnell D, von Moltke L. Pharmacokinetics and Short-term Safety of ALKS 3831, a Fixed-dose Combination of Olanzapine and Samidorphan, in Adult Subjects with Schizophrenia. Clin Ther. 2018 Nov;40(11):1845-1854.e2. doi: 10.1016/j.clinthera.2018.09.002. Epub 2018 Oct 20.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ACTUAL): August 1, 2016
• Study Completion (ACTUAL): August 1, 2016

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (ESTIMATE): June 17, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): September 22, 2016
• Last Update Submitted That Met QC Criteria: September 21, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Schizophrenia; Alkermes; Samidorphan; ALK 3831
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: ALK3831-A104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED