An Insulin Sensitivity Study in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Placebo; Drug: ALKS 3831; Drug: Olanzapine

• Registration Number: NCT02922426
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-30
• Study First Submitted QC: 2016-09-30
• Study First Posted: 2016-10-04
• Primary Completion: 2017-07-20
• Study Completion: 2017-07-20
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-18
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Oral, bilayer tablet
ALKS 3831	ALKS 3831	Oral, bilayer tablet
Olanzapine	Olanzapine	Oral, bilayer tablet

Primary Outcome Measures

Name	Time	Method
Changes in blood glucose concentrations	21 days	Differences will be compared among treatment groups

Secondary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events (AEs)	24 days
Changes in insulin concentrations	21 days	Differences will be compared among treatment groups

Trial Locations

Locations (1)

Alkermes Investigational Site; 🇺🇸 Chula Vista, California, United States