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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY3372689; Diagnostic test: [18F]LSN3316612

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Invicro, Institute for Neurodegenerative Disorders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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• Have previously participated or withdrawn from this study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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: [18F]MNI-1068

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2019
• Primary Completion (Actual): February 19, 2020
• Study Completion (Actual): February 19, 2020

Study Registration Dates

• First Submitted: May 2, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (Actual): May 9, 2019

Study Record Updates

• Last Update Posted (Actual): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 21, 2020
• Last Verified: April 15, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 17220; I9X-MC-MTAB (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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