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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03944031
Recruitment Status : Completed
First Posted : May 9, 2019
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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 approximately 25 days after enrollment. Screening must be completed within 28 days prior to enrollment.

Condition or disease Intervention/treatment Phase
Healthy Drug: LY3372689 Diagnostic Test: [18F]LSN3316612 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 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 Single Oral Doses of LY3372689 as Measured by Positron Emission Tomography (PET) With the Radioligand [18F]LSN3316612 in Healthy Subjects
Actual Study Start Date : May 8, 2019
Actual Primary Completion Date : February 19, 2020
Actual Study Completion Date : February 19, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3372689 + [18F]LSN3316612
LY3372689 administered orally followed by [18F]LSN3316612 PET tracer administered intravenously (IV) approximately 2 - 72 hours later.
 Drug: LY3372689
Administered orally.

Diagnostic Test: [18F]LSN3316612
Administered IV.
Other Name: [18F]MNI-1068


Outcome Measures
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Primary Outcome Measures :
  1. Percent O-GlcNAcase (OGA) Enzyme Occupancy (EO) [ Time Frame: Predose Scan (Days -14 to -1) ]
    Percent OGA EO

  2. Percent OGA EO [ Time Frame: Postdose Scan 1 (Days 1 - 4) ]
    Percent OGA EO

  3. Percent OGA EO [ Time Frame: Postdose Scan 2 (Days 2 - 4) ]
    Percent OGA EO


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Overtly healthy males or females who cannot get pregnant
  • Have a body mass index (BMI) of at least 18.5 kilogram 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 veins and arteries suitable for protocol required 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
  • Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking for study procedure
  • 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
  • Have long exposure to sunlight routinely or use tanning beds regularly
  • Participate in regular vigorous exercise
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03944031


Locations
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United States, Connecticut
Invicro, Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03944031    
Other Study ID Numbers: 17220
I9X-MC-MTAB ( Other Identifier: Eli Lilly and Company )
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 15, 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes