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A Study of Food Effect on Tersolisib (LY4064809) in Healthy Participants
Sponsor: Eli Lilly and Company
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
Tersolisib
Tersolisib administered orally
High-fat Meal
High-fat Meal
Low-fat Meal
Low-fat Meal
Locations (2)
Lenexa Clinic
Lenexa, Kansas, United States
ICON Early Phase Services, LLC
San Antonio, Texas, United States