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
2 other identifiers
interventional
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started May 2019
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2019
CompletedStudy Start
First participant enrolled
May 8, 2019
CompletedFirst Posted
Study publicly available on registry
May 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 19, 2020
CompletedApril 22, 2020
April 15, 2020
10 months
May 2, 2019
April 21, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
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)
Study Arms (1)
LY3372689 + [18F]LSN3316612
EXPERIMENTALLY3372689 administered orally followed by \[18F\]LSN3316612 PET tracer administered intravenously (IV) approximately 2 - 72 hours later.
Interventions
Administered IV.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Invicro, Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510, United States
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2019
First Posted
May 9, 2019
Study Start
May 8, 2019
Primary Completion
February 19, 2020
Study Completion
February 19, 2020
Last Updated
April 22, 2020
Record last verified: 2020-04-15
Data Sharing
- IPD Sharing
- Will not share