An Insulin Sensitivity Study in Healthy Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID: NCT02922426
Run by: Alkermes, Inc.
People needed: 60
Starts: 2016-09-01
Expected to finish: 2017-07-20
Last updated by the study team: 2017-08-22

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Alkermes Investigational Site — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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