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An Insulin Sensitivity Study in Healthy Subjects

Primary Purpose

Healthy Volunteers

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ALKS 3831
Olanzapine
Placebo
Sponsored by
Alkermes, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Volunteers focused on measuring ALKS 3831, Samidorphan, Olanzapine

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Alkermes Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

ALKS 3831

Olanzapine

Placebo

Arm Description

Oral, bilayer tablet

Oral, bilayer tablet

Oral, bilayer tablet

Outcomes

Primary Outcome Measures

Changes in blood glucose concentrations
Differences will be compared among treatment groups

Secondary Outcome Measures

Changes in insulin concentrations
Differences will be compared among treatment groups
Incidence of treatment-emergent adverse events (AEs)

Full Information

First Posted
September 30, 2016
Last Updated
August 18, 2017
Sponsor
Alkermes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02922426
Brief Title
An Insulin Sensitivity Study in Healthy Subjects
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 Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
July 20, 2017 (Actual)
Study Completion Date
July 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alkermes, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers
Keywords
ALKS 3831, Samidorphan, Olanzapine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALKS 3831
Arm Type
Experimental
Arm Description
Oral, bilayer tablet
Arm Title
Olanzapine
Arm Type
Active Comparator
Arm Description
Oral, bilayer tablet
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral, bilayer tablet
Intervention Type
Drug
Intervention Name(s)
ALKS 3831
Intervention Description
Daily dosing for 21 consecutive days
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Description
Daily dosing for 21 consecutive days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Daily dosing for 21 consecutive days
Primary Outcome Measure Information:
Title
Changes in blood glucose concentrations
Description
Differences will be compared among treatment groups
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Changes in insulin concentrations
Description
Differences will be compared among treatment groups
Time Frame
21 days
Title
Incidence of treatment-emergent adverse events (AEs)
Time Frame
24 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
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
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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An Insulin Sensitivity Study in Healthy Subjects

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