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A Phase 1 Safety Study in Adults With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02804568
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : September 22, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: ALKS 3831 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multiple-dose, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALKS 3831 in Adult Subjects With Schizophrenia
Study Start Date : June 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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




Primary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: Up to 15 days of dosing ]
  2. 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 Measures :
  1. Safety will be determined by incidence of drug-related adverse events [ Time Frame: Up to 21 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804568


Locations
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United States, Arkansas
Alkermes Investigational Site
Little Rock, Arkansas, United States, 72205
United States, New Jersey
Alkermes Investigational Site
Clementon, New Jersey, United States, 08021
United States, Ohio
Alkermes Investigational Site
Dayton, Ohio, United States, 45417
Sponsors and Collaborators
Alkermes, Inc.
Investigators
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Study Director: David McDonnell, MD Alkermes, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT02804568     History of Changes
Other Study ID Numbers: ALK3831-A104
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Alkermes, Inc.:
Schizophrenia
Alkermes
ALK 3831
Samidorphan
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders