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NOT YET RECRUITING
NCT07662798
PHASE1

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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.

Official title: A Phase 1, Open-label Study to Assess the Effect of Food on the Pharmacokinetics of Tersolisib Administered Under Fasted Conditions, With a High-fat Meal, and With a Low-fat Meal, in Healthy Participants

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-07

Completion Date

2026-09

Last Updated

2026-06-23

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Tersolisib

Tersolisib administered orally

OTHER

High-fat Meal

High-fat Meal

OTHER

Low-fat Meal

Low-fat Meal

Locations (2)

Lenexa Clinic

Lenexa, Kansas, United States

ICON Early Phase Services, LLC

San Antonio, Texas, United States