A Study of LY3857210 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3857210

• Registration Number: NCT05292040
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-14
• Study Start: 2022-03-17
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-23
• Primary Completion: 2022-12-14
• Study Completion: 2022-12-14
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LY3857210	LY3857210	Single doses of LY3857210 administered orally.

Primary Outcome Measures

Name	Time	Method
Change from baseline in brain receptor occupancy (RO) of LY3857210 measured by [18F]-LY3818850 PET scan	Baseline through study completion, up to approximately 6 weeks	Change from baseline in brain RO of LY3857210 measured by \[18F\]-LY3818850 PET scan

Trial Locations

Locations (1)

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