A Study of LY3857210 in Healthy Participants

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05292040
• Other study ID #: 18313
• Secondary ID: J3O-MC-LSBA
• Status: Completed
• Phase: Phase 1
• Start date: March 17, 2022
• Est. completion date: December 14, 2022

Study information

• Verified date: February 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 14, 2022
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3857210
Administered orally.

Locations

Country	Name	City	State
United States	Invicro, Institute for Neurodegenerative Disorders	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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