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NCT07662798PHASE1RecruitingAccepts Healthy Volunteers

A Study of Food Effect on Tersolisib (LY4064809) in Healthy Participants

Eli Lilly and Company

Start Date

7/1/2026

Completion Date

9/1/2026

Summary

The main purpose of this study is to measure how food affects the amount of tersolisib that gets into the bloodstream. Each participant will receive two single oral doses of tersolisib, one under fasted conditions and one with either a high-fat or a low-fat meal. Blood tests will be performed to investigate how the body processes the study drug under each condition. For each participant, the study will last about 9 weeks and will include a stay in the Clinical Research Unit (CRU) lasting almost a month.

Eligibility Criteria

Age Range: 18 years to 55 years

Inclusion Criteria: * Are healthy as determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations. * Normal blood pressure and pulse rate. * Body mass index (BMI) within the range 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive. * Participants assigned male at birth (AMAB) or participants assigned female at birth (AFAB) who are individuals not of childbearing potential (INOCBP). Exclusion Criteria: * History or presence of any of the following conditions, deemed clinically significant by the investigator (or designee): * Metabolic disease, including congenital non-hemolytic hyperbilirubinemia, for example, Gilbert syndrome * Biliary disease, including cholecystectomy * Gastrointestinal (GI) disease * Hematological disease * Neurological disease * Significant history of, or presence of liver disease, including abnormal liver function tests above 1.25 times the upper limit of normal range per the laboratory's reference ranges at screening or admission, or * Clinically significant, active cardiovascular disease or history of myocardial infarction or significant cardiovascular disease. * History of a major surgical procedure within 30 days prior to screening. * Known allergies to tersolisib or related compounds.

Interventions

DRUG

Tersolisib

OTHER

High-fat Meal

OTHER

Low-fat Meal

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Conditions

Healthy

Locations

Lenexa Clinic

Lenexa, Kansas 66219

United States

ICON Early Phase Services, LLC

San Antonio, Texas 78232

United States