An Insulin Sensitivity Study in Healthy Subjects

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

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

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: ALKS 3831
* Drug: Olanzapine
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALKS 3831<br>Oral, bilayer tablet | Drug: ALKS 3831<br>* Daily dosing for 21 consecutive days<br>|
| Active Comparator: Olanzapine<br>Oral, bilayer tablet | Drug: Olanzapine<br>* Daily dosing for 21 consecutive days<br>|
| Placebo Comparator: Placebo<br>Oral, bilayer tablet | Drug: Placebo<br>* Daily dosing for 21 consecutive days<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALKS 3831, Samidorphan, Olanzapine