An Insulin Sensitivity Study in Healthy Subjects

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Double-Blind, Parallel-Group Study in Healthy Subjects to Characterize Insulin Sensitivity and Lipid Metabolism in Response to Treatment With ALKS 3831 and Olanzapine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922426
• Other study ID #: ALK3831-A108
• Status: Completed
• Phase: Phase 1
• First received: September 30, 2016
• Last updated: August 18, 2017
• Start date: September 2016
• Est. completion date: July 20, 2017

Study information

• Verified date: August 2017
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 20, 2017
• Est. primary completion date: July 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers
• Insulin Resistance

Intervention

Drug:
• ALKS 3831
Daily dosing for 21 consecutive days
• Olanzapine
Daily dosing for 21 consecutive days
• Placebo
Daily dosing for 21 consecutive days

Locations

Country	Name	City	State
United States	Alkermes Investigational Site	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in blood glucose concentrations	Differences will be compared among treatment groups	21 days
Secondary	Changes in insulin concentrations	Differences will be compared among treatment groups	21 days
Secondary	Incidence of treatment-emergent adverse events (AEs)		24 days