NCT02804568

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 schizophrenia

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_1 schizophrenia

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 22, 2016

Status Verified

September 1, 2016

Enrollment Period

2 months

First QC Date

June 15, 2016

Last Update Submit

September 21, 2016

Conditions

Schizophrenia

Keywords

SchizophreniaAlkermesALK 3831Samidorphan

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Safety will be determined by incidence of drug-related adverse events

    Up to 21 days

Study Arms (2)

Group 1

EXPERIMENTAL

Olanzapine/samidorphan 10 mg/10 mg

Drug: ALKS 3831

Group 2

EXPERIMENTAL

Olanzapine/samidorphan 20 mg/10 mg

Drug: ALKS 3831

Interventions

ALKS 3831DRUG

Oral capsule, daily administration

Group 1Group 2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Alkermes Investigational Site

Little Rock, Arkansas, 72205, United States

Location

Alkermes Investigational Site

Clementon, New Jersey, 08021, United States

Location

Alkermes Investigational Site

Dayton, Ohio, 45417, United States

Location

Related Publications (1)

  • 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.

    PMID: 30348514DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • David McDonnell, MD

    Alkermes, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 17, 2016

Study Start

June 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 22, 2016

Record last verified: 2016-09

Locations

US(3)