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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3372689; Diagnostic Test: [18F]LSN3316612

• Registration Number: NCT04392271
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-05-14
• Study First Posted: 2020-05-18
• Study Start: 2020-08-06
• Primary Completion: 2020-10-14
• Study Completion: 2020-10-14
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

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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• Have previously participated or withdrawn from this study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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percent O-GlcNAcase (OGA) Enzyme Occupancy (EO)	Approximately 2 to 96 hours following the first dose	Percent OGA EO
Percent OGA EO	Approximately 2 to 96 hours following the last dose	Percent OGA EO

Secondary Outcome Measures

Name	Time	Method
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
PK: Maximum Concentration (Cmax) of LY3372689	Baseline through 24 hours	PK: Cmax of LY3372689

Trial Locations

Locations (1)

Institute for Neurodegenerative Disorders; 🇺🇸 New Haven, Connecticut, United States