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Completed

NCT Number: NCT05292040

A Study of LY3857210 in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Invicro, Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3857210

Drug

Administered orally.

Primary outcomes

  1. Change from baseline in brain receptor occupancy (RO) of LY3857210 measured by [18F]-LY3818850 PET scan

    Time frame: Baseline through study completion, up to approximately 6 weeks

    Change from baseline in brain RO of LY3857210 measured by [18F]-LY3818850 PET scan

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 23, 2022
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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