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A Phase 1 Safety Study in Adults With Schizophrenia

Primary Purpose

Schizophrenia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ALKS 3831

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Alkermes, ALK 3831, Samidorphan

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Alkermes Investigational Site
Alkermes Investigational Site
Alkermes Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group 1

Group 2

Arm Description

Olanzapine/samidorphan 10 mg/10 mg

Olanzapine/samidorphan 20 mg/10 mg

Outcomes

Primary Outcome Measures

Maximum plasma concentration (Cmax)

Area under the concentration vs time curve over the 24 hour dosing interval (AUC0-24h)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02804568

First Posted

June 15, 2016

Last Updated

September 21, 2016

Sponsor

Alkermes, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02804568

Brief Title

A Phase 1 Safety Study in Adults With Schizophrenia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

June 2016 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alkermes, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

Schizophrenia, Alkermes, ALK 3831, Samidorphan

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Olanzapine/samidorphan 10 mg/10 mg

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Olanzapine/samidorphan 20 mg/10 mg

Intervention Type

Drug

Intervention Name(s)

ALKS 3831

Intervention Description

Oral capsule, daily administration

Primary Outcome Measure Information:

Title

Maximum plasma concentration (Cmax)

Time Frame

Up to 15 days of dosing

Title

Area under the concentration vs time curve over the 24 hour dosing interval (AUC0-24h)

Time Frame

Up to 15 days of dosing

Secondary Outcome Measure Information:

Title

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

Time Frame

Up to 21 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David McDonnell, MD

Organizational Affiliation

Alkermes, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Alkermes Investigational Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Alkermes Investigational Site

City

Clementon

State/Province

New Jersey

ZIP/Postal Code

08021

Country

United States

Facility Name

Alkermes Investigational Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45417

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

30348514

Citation

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.

Results Reference

derived

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A Phase 1 Safety Study in Adults With Schizophrenia

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