An Insulin Sensitivity Study in Healthy Subjects

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: ALKS 3831; Drug: Olanzapine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91911
      • Alkermes Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in blood glucose concentrations	Differences will be compared among treatment groups	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in insulin concentrations	Differences will be compared among treatment groups	21 days
Incidence of treatment-emergent adverse events (AEs)		24 days

Collaborators and Investigators

• Sponsor: Alkermes, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): July 20, 2017
• Study Completion (Actual): July 20, 2017

Study Registration Dates

• First Submitted: September 30, 2016
• First Submitted That Met QC Criteria: September 30, 2016
• First Posted (Estimate): October 4, 2016

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 18, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Samidorphan; Olanzapine; ALKS 3831
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Olanzapine
• Other Study ID Numbers: ALK3831-A108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided