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A Study of the Effects of Multiple Doses of LY3372689 on the Brain in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04392271
Collaborator
(none)
4
Enrollment
1
Location
1
Arm
2.3
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study uses imaging to evaluate how LY3372689 binds to a protein in the brain. This study will be conducted in healthy participants and will last up to about 10 weeks. Screening must be completed within four weeks prior to enrollment.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Assessment of Brain O-GlcNAcase (OGA) Enzyme Occupancy After Multiple Oral Doses of LY3372689 as Measured by Positron Emission Tomography (PET) With the Radioligand [18F]LY3316612 in Healthy Subjects
Actual Study Start Date :
Aug 6, 2020
Actual Primary Completion Date :
Oct 14, 2020
Actual Study Completion Date :
Oct 14, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3372689 + [18F]LSN3316612

LY3372689 administered orally followed by [18F]LSN3316612 PET tracer administered intravenously (IV) approximately 24 hours later.

Drug: LY3372689
Administered orally.

Diagnostic Test: [18F]LSN3316612
Administered intravenously (IV).
Other Names:
  • [18F]MNI-1068

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percent O-GlcNAcase (OGA) Enzyme Occupancy (EO) [Approximately 2 to 96 hours following the first dose]

      Percent OGA EO

    2. Percent OGA EO [Approximately 2 to 96 hours following the last dose]

      Percent OGA EO

    Secondary Outcome Measures

    1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During the Dosing Interval (AUC[0-tau]) of LY3372689 [Baseline through 24 hours]

      PK: AUC(0-tau) of LY3372689

    2. PK: Maximum Concentration (Cmax) of LY3372689 [Baseline through 24 hours]

      PK: Cmax of LY3372689

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Overtly healthy males or females who do not have child-bearing potential

    • Have a body mass index (BMI) of greater than (>)18 to less than or equal to (≤32) kilograms per square meter (kg/m²), inclusive, at screening

    • Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study

    • Have venous access sufficient to allow for blood sampling

    Exclusion Criteria:

    • Have a history of head injury or contraindications to undergoing magnetic resonance imaging (MRI) examination

    • Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study

    • Have previously participated or withdrawn from this study

    • Have had prior participation in other research protocols or clinical care in the preceding year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds the effective dose of 50 milliSievert (mSv), which would be above the acceptable annual limit established by the US Federal Guidelines

    • Are current smokers or have used tobacco or nicotine-containing products as determined by the cotinine test

    • Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate or could interfere with understanding the results of the study

    • Participate in regular vigorous exercise

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institute for Neurodegenerative Disorders New Haven Connecticut United States 06510

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04392271
    Other Study ID Numbers:
    • 17243
    • I9X-MC-MTAD
    First Posted:
    May 18, 2020
    Last Update Posted:
    Nov 4, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 4, 2020