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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Tersolisib; Other: High-fat Meal; Other: Low-fat Meal

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: LillyTrials@Lilly.com
• Study Contact Backup: Name: Physicians interested in becoming principal investigators please contact; Email: clinical_inquiry_hub@lilly.com

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Lenexa Clinic
  • Texas
    • San Antonio, Texas, United States, 78232
      • ICON Early Phase Services, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 Treatment A Fasted; Tersolisib administered orally.	Drug: Tersolisib; Tersolisib administered orally; Other Names: LY4064809
Experimental: Group 1 Treatment B High-Fat Meal; Tersolisib administered orally.	Drug: Tersolisib; Tersolisib administered orally; Other Names: LY4064809; Other: High-fat Meal; High-fat Meal
Experimental: Group 2 Treatment A Fasted; Tersolisib administered orally.	Drug: Tersolisib; Tersolisib administered orally; Other Names: LY4064809
Experimental: Group 2 Treatment C Low-Fat Meal; Tersolisib administered orally.	Drug: Tersolisib; Tersolisib administered orally; Other Names: LY4064809; Other: Low-fat Meal; Low-fat Meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 27883; J6M-MC-JSGJ (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No