Healthy Volunteers
Conditions
Keywords
ALKS 3831, Samidorphan, Olanzapine
Brief summary
This study will characterize insulin sensitivity in response to treatment with ALKS 3831, olanzapine, and placebo.
Interventions
DRUGALKS 3831
Daily dosing for 21 consecutive days
DRUGOlanzapine
Daily dosing for 21 consecutive days
DRUGPlacebo
Daily dosing for 21 consecutive days
Sponsors
Alkermes, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in blood glucose concentrations | 21 days | Differences will be compared among treatment groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in insulin concentrations | 21 days | Differences will be compared among treatment groups |
| Incidence of treatment-emergent adverse events (AEs) | 24 days | — |
Countries
United States
Outcome results
None listed