A Study of LY3857210 in Healthy Participants
An Adaptive Design, Phase 1, Open-label Study to Investigate Receptor Occupancy in Brain After Single Oral Doses of LY3857210 as Measured by Positron Emission Tomography (PET) With the Radioligand [18F]-LY3818850 in Healthy Participants
2 other identifiers
interventional
10
1 country
1
Brief Summary
The main purpose of this study is to evaluate the presence of study drug LY3857210 in the brain measured by positron emission tomography (PET) with the radioligand \[18F\]-LY3818850 in healthy participants. The safety and tolerability of LY3857210 will also be evaluated. The study will last up to approximately 6 weeks for each participant and may include up to four visits to the study center.
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 Mar 2022
Typical duration 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
March 14, 2022
CompletedStudy Start
First participant enrolled
March 17, 2022
CompletedFirst Posted
Study publicly available on registry
March 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2022
CompletedMarch 1, 2023
February 1, 2023
9 months
March 14, 2022
February 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in brain receptor occupancy (RO) of LY3857210 measured by [18F]-LY3818850 PET scan
Change from baseline in brain RO of LY3857210 measured by \[18F\]-LY3818850 PET scan
Baseline through study completion, up to approximately 6 weeks
Study Arms (1)
LY3857210
EXPERIMENTALSingle doses of LY3857210 administered orally.
Interventions
Eligibility Criteria
You may qualify if:
- Overtly healthy male or female participants as determined by medical evaluation
- Have body weight ≥ 45 kilograms (kg) and body mass index (BMI) within the range 18.5 to 32.0 kilograms per square meter (kg/m²) (inclusive)
- Are males and in agreement to follow contraceptive requirements, or women of non-child-bearing potential
You may not qualify if:
- Have contraindications to undergoing magnetic resonance imaging (MRI) examination including but not limited to implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips, and other medical implants that have not been certified for head MRI
- Have clinically significant findings on the screening MRI scan, as judged by the investigator
- Suffer from claustrophobia and would be unable to tolerate the confined spaces of MRI or PET camera
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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2022
First Posted
March 23, 2022
Study Start
March 17, 2022
Primary Completion
December 14, 2022
Study Completion
December 14, 2022
Last Updated
March 1, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share