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

Recruiting now · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT07662798

Run by

Eli Lilly and Company

People needed

60

Starts

2026-07-01

Expected to finish

2026-09-01

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Lenexa Clinic — Lenexa, Kansas, United States (enrolling)
• ICON Early Phase Services, LLC — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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