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NCT Number: NCT07662798

A Study of Food Effect on Tersolisib (LY4064809) 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.

Recruiting

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lenexa Clinic, Lenexa, Kansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tersolisib

Drug

Tersolisib administered orally

Other names: LY4064809

High-fat Meal

Other

High-fat Meal

Low-fat meal

Other

Low-fat Meal

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tersolisib

    Time frame: Predose on Day 1 Through Day 28

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of Tersolisib

    Time frame: Predose on Day 1 Through Day 28

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 23, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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