Skip to main content
OpenTrials
Completed

NCT Number: NCT02922426

An Insulin Sensitivity Study in Healthy Subjects

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Alkermes Investigational Site

Chula Vista, California, 91911, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALKS 3831

Drug

Daily dosing for 21 consecutive days

Olanzapine

Drug

Daily dosing for 21 consecutive days

Placebo

Drug

Daily dosing for 21 consecutive days

Primary outcomes

  1. Changes in blood glucose concentrations

    Time frame: 21 days

    Differences will be compared among treatment groups

Secondary outcomes

  1. Changes in insulin concentrations

    Time frame: 21 days

    Differences will be compared among treatment groups

  2. Incidence of treatment-emergent adverse events (AEs)

    Time frame: 24 days

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 4, 2016
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.