A Study of LY4064809 in Healthy Adult Chinese Participants

Lilly

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: LY4064809

Study type

Interventional

Funder types

Industry

Identifiers

NCT07247357

J6M-MC-JSGE (Other Identifier)

27745

Details and patient eligibility

About

The main purpose of this study is to measure how much LY4064809 gets into the bloodstream and how long it takes the body to eliminate it in healthy participants. It also looks at safety and tolerability in healthy participants. The study drug will be administered orally. The study will last approximately 21 days, excluding screening.

Enrollment

10 patients

Sex

All

Ages

21 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Are native Chinese. To qualify as a native Chinese for the purpose of this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China
Are overtly healthy as determined by medical evaluation, including medical history, physical examination, vital signs, and electrocardiogram (ECG) at screening and admission
Have clinical laboratory test results within the normal range for the population or investigative site, or with abnormalities deemed not clinically significant by the investigator at screening
Have a body mass index within the range 18 to 32 kilogram per square meter (kg/m²)

Exclusion criteria

History or presence of any of the following conditions, deemed clinically significant by the investigator (or designee), which may significantly alter the absorption, metabolism, or elimination of drugs, constitute a risk when taking the study intervention, or interfere with the data interpretation:
- metabolic disease, including congenital non-hemolytic hyperbilirubinemia, for example, Gilbert syndrome
- bile duct disease, including removal of the gall bladder
- digestive system disease
- blood disease
- disease of the nervous system
- significant history of, or presence of, liver disease, including any abnormal liver function tests, as defined by aspartate aminotransferase, alanine transaminase, or transducin beta-like above the 1.5× upper limit of normal range per the laboratory's reference ranges at screening, or
- clinically significant, active cardiovascular disease or history of heart attack within 6 months prior to the planned start of LY4064809
Have a 12-lead ECG abnormality at screening or admission
History of a major surgical procedure within 30 days prior to screening
Diagnosed or treated cancer within 5 years prior to screening
Have known allergies to LY4064809 or related compounds