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