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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3372689
* Diagnostic Test: [18F]LSN3316612


Participation Criteria
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Eligibility Criteria
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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30 days or any other type of medical research judged to be incompatible with this study Have previously participated or withdrawn from this study Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking for study procedure Have or used to have health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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3372689 + [18F]LSN3316612<br>LY3372689 administered orally followed by [18F]LSN3316612 PET tracer administered intravenously (IV) approximately 2 - 72 hours later. | Drug: LY3372689<br>* Administered orally.<br>Diagnostic Test: [18F]LSN3316612<br>* Administered IV.<br>* Other names: [18F]MNI-1068;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent O-GlcNAcase (OGA) Enzyme Occupancy (EO) | Percent OGA EO | Predose Scan (Days -14 to -1) | 
| Percent OGA EO | Percent OGA EO | Postdose Scan 1 (Days 1 - 4) | 
| Percent OGA EO | Percent OGA EO | Postdose Scan 2 (Days 2 - 4) |