Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Insulin Sensitivity Study in Healthy Subjects

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: NCT02922426
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Brief Summary:
This study will characterize insulin sensitivity in response to treatment with ALKS 3831, olanzapine, and placebo.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: ALKS 3831 Drug: Olanzapine Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group Study in Healthy Subjects to Characterize Insulin Sensitivity and Lipid Metabolism in Response to Treatment With ALKS 3831 and Olanzapine
Study Start Date : September 2016
Actual Primary Completion Date : July 20, 2017
Actual Study Completion Date : July 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ALKS 3831
Oral, bilayer tablet
Drug: ALKS 3831
Daily dosing for 21 consecutive days

Active Comparator: Olanzapine
Oral, bilayer tablet
Drug: Olanzapine
Daily dosing for 21 consecutive days

Placebo Comparator: Placebo
Oral, bilayer tablet
Drug: Placebo
Daily dosing for 21 consecutive days




Primary Outcome Measures :
  1. Changes in blood glucose concentrations [ Time Frame: 21 days ]
    Differences will be compared among treatment groups


Secondary Outcome Measures :
  1. Changes in insulin concentrations [ Time Frame: 21 days ]
    Differences will be compared among treatment groups

  2. Incidence of treatment-emergent adverse events (AEs) [ Time Frame: 24 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index (BMI) between 18.0 and < 25.0 kg/m^2 at screening and randomization
  • No prior history of regular smoking or nicotine use
  • Women of child-bearing potential should be on stable regimens of oral contraceptives for at least 2 months prior to screening
  • Subjects must be willing to avoid a regular exercise regimen from screening through the end of the treatment period
  • Additional criteria may apply

Exclusion Criteria:

  • Has current evidence or history of any clinically significant medical or psychiatric condition or observed abnormality
  • Is currently pregnant or breastfeeding, or is planning to become pregnant during the study
  • Has a lifetime history of diabetes
  • Has a known risk of narrow-angle glaucoma
  • Has a clinically significant illness within 30 days prior to screening or admission to the clinic
  • Has a history of dependence on any substance other than caffeine
  • Has a current or anticipated need for prescribed opioid medication (eg, planned surgery) during the study period
  • Has a positive urine drug screen for drugs of abuse at screening or admission to the study site
  • Has had a serious infection (eg, pneumonia or septicemia) within the 3 months prior to screening or admission to the clinic
  • Has had any vaccinations in the 4 weeks prior to screening or admission to the clinic
  • Chronic use of non-steroid anti-inflammatory drugs (NSAIDs) and acetaminophen, except for low-dose Aspirin is not allowed
  • Use of new prescription and non-prescription drugs, as well as dietary/nutritional supplements within 3 weeks preceding the first dosing of study drugs, unless approved by Investigator
  • Has prior use of any antipsychotic medication, including on and off label uses
  • 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): NCT02922426


Locations
Layout table for location information
United States, California
Alkermes Investigational Site
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Alkermes, Inc.
Investigators
Layout table for investigator information
Study Director: David McDonnell, MD Alkermes, Inc.

Layout table for additonal information
Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT02922426    
Other Study ID Numbers: ALK3831-A108
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Alkermes, Inc.:
ALKS 3831
Samidorphan
Olanzapine
Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Olanzapine
Hypoglycemic Agents
Physiological Effects of Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents