NCT07662798

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1 healthy

Timeline
1mo left

Started Jul 2026

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Jul 2026Sep 2026

First Submitted

Initial submission to the registry

June 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

June 17, 2026

Last Update Submit

July 15, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (4)

Group 1 Treatment A Fasted

EXPERIMENTAL

Tersolisib administered orally.

Drug: Tersolisib

Group 1 Treatment B High-Fat Meal

EXPERIMENTAL

Tersolisib administered orally.

Drug: TersolisibOther: High-fat Meal

Group 2 Treatment A Fasted

EXPERIMENTAL

Tersolisib administered orally.

Drug: Tersolisib

Group 2 Treatment C Low-Fat Meal

EXPERIMENTAL

Tersolisib administered orally.

Drug: TersolisibOther: Low-fat Meal

Interventions

TersolisibDRUG

Tersolisib administered orally

Also known as: LY4064809
Group 1 Treatment A FastedGroup 1 Treatment B High-Fat MealGroup 2 Treatment A FastedGroup 2 Treatment C Low-Fat Meal
High-fat MealOTHER

High-fat Meal

Group 1 Treatment B High-Fat Meal
Low-fat MealOTHER

Low-fat Meal

Group 2 Treatment C Low-Fat Meal

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lenexa Clinic

Lenexa, Kansas, 66219, United States

RECRUITING

ICON Early Phase Services, LLC

San Antonio, Texas, 78232, United States

RECRUITING

Study Officials

  • 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 DIRECTOR

Central Study Contacts

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

CONTACT

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2026

First Posted

June 23, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)