Overview

An Insulin Sensitivity Study in Healthy Subjects

Status:
Completed
Trial end date:
2017-07-20
Target enrollment:
0
Participant gender:
All
Summary
This study will characterize insulin sensitivity in response to treatment with ALKS 3831, olanzapine, and placebo.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Alkermes, Inc.
Treatments:
Insulin
Olanzapine
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