An Insulin Sensitivity Study in Healthy Subjects

NCT02922426 | Completed Phase 1

• 1 other identifier: ALK3831-A108
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

ALKS 3831; Samidorphan; Olanzapine

Outcome Measures

Primary Outcomes (1)

• Changes in blood glucose concentrations

  Differences will be compared among treatment groups

  21 days

Secondary Outcomes (2)

• Changes in insulin concentrations

  21 days

• Incidence of treatment-emergent adverse events (AEs)

  24 days

Study Arms (3)

ALKS 3831

EXPERIMENTAL

Oral, bilayer tablet

Drug: ALKS 3831

Olanzapine

ACTIVE COMPARATOR

Oral, bilayer tablet

Drug: Olanzapine

Placebo

PLACEBO COMPARATOR

Oral, bilayer tablet

Drug: Placebo

Interventions

ALKS 3831 DRUG

Daily dosing for 21 consecutive days

ALKS 3831

Olanzapine DRUG

Daily dosing for 21 consecutive days

Olanzapine

Placebo DRUG

Daily dosing for 21 consecutive days

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (1)

Alkermes Investigational Site

Chula Vista, California, 91911, United States

Location

MeSH Terms

Interventions

Olanzapine

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• David McDonnell, MD

  Alkermes, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: October 4, 2016
• Study Start: September 1, 2016
• Primary Completion: July 20, 2017
• Study Completion: July 20, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

US (1)