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Active, not recruitingNCT07662798Updated Aug 19, 2026

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

A Phase 1 interventional study of Tersolisib and High-fat Meal in Healthy, sponsored by Eli Lilly and Company. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 139 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Group 1 Treatment A Fasted

    Tersolisib administered orally.

    Drug: Tersolisib

  • Experimental
    Group 1 Treatment B High-Fat Meal

    Tersolisib administered orally.

    Drug: Tersolisib · Other: High-fat Meal

  • Experimental
    Group 2 Treatment A Fasted

    Tersolisib administered orally.

    Drug: Tersolisib

  • Experimental
    Group 2 Treatment C Low-Fat Meal

    Tersolisib administered orally.

    Drug: Tersolisib · Other: Low-fat Meal

Interventions

  • DrugTersolisib

    Tersolisib administered orally

    Also known as: LY4064809

  • OtherHigh-fat Meal

    High-fat Meal

  • OtherLow-fat Meal

    Low-fat Meal

06

What researchers measure

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

07

Study locations

2 sites
  • Lenexa Clinic
    Lenexa, Kansas 66219, United States
  • ICON Early Phase Services, LLC
    San Antonio, Texas 78232, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07662798
Responsible party
Sponsor
First posted
Jun 23, 2026
Start date
Jul 1, 2026
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Aug 19, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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