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

NCT07662798 — Phase 1, Completed, 60 participants, Eli Lilly and Company

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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

Registry	NCT07662798
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, basic science
Enrollment	60 (Actual)
Sponsor	Eli Lilly and Company (Industry)
Conditions	Healthy
Interventions	Tersolisib, High-fat Meal, Low-fat Meal (Drug, other)
Dates	start 2026-07-01, primary completion 2026-09-03, completion 2026-09-03, first posted 2026-06-23, last updated 2026-10-14
Locations	2 sites in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Group 1 Treatment A Fasted	Experimental	Drug: Tersolisib	Tersolisib administered orally.
Group 1 Treatment B High-Fat Meal	Experimental	Drug: Tersolisib; Other: High-fat Meal	Tersolisib administered orally.
Group 2 Treatment A Fasted	Experimental	Drug: Tersolisib	Tersolisib administered orally.
Group 2 Treatment C Low-Fat Meal	Experimental	Drug: Tersolisib; Other: Low-fat Meal	Tersolisib administered orally.

Tersolisib (Drug), also known as LY4064809: Tersolisib administered orally
High-fat Meal (Other): High-fat Meal
Low-fat Meal (Other): Low-fat Meal

+Outcome measures

Primary outcomes

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tersolisib [Predose on Day 1 Through Day 28]
PK: Area Under the Concentration Versus Time Curve (AUC) of Tersolisib [Predose on Day 1 Through Day 28]

+Eligibility

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

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.

+Locations (2)

Facility	City	Country	Status
Lenexa Clinic	Lenexa, Kansas	United States
ICON Early Phase Services, LLC	San Antonio, Texas	United States

+Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company