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Meal timing may change how this drug enters the bloodstream

NCT ID NCT07662798

Knowledge-focused Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 4 times

Summary

This study looks at how eating a high-fat or low-fat meal changes the way the body absorbs the drug tersolisib. Healthy volunteers receive two doses of tersolisib—one on an empty stomach and one with a meal—and have blood tests to measure drug levels. The goal is to understand whether food affects how much of the drug gets into the bloodstream, which can guide future dosing instructions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tersolisib
What this could lead to
Results could help determine whether tersolisib should be taken with or without food for best absorption.
What could go wrong
This is an early-phase study in healthy people, not patients. Findings may not predict real-world use or safety.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy

Contacts and locations

Locations

  • ICON Early Phase Services, LLC

    San Antonio, Texas, 78232, United States

  • Lenexa Clinic

    Lenexa, Kansas, 66219, United States

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