Healthy
Conditions
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.
Interventions
DRUGLY3857210
Administered orally.
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed