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Healthy volunteers help uncover best way to take cancer pill

NCT ID NCT05468164

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This completed Phase 1 study looked at how food and the heartburn drug omeprazole affect the absorption of selpercatinib, a cancer medication. Twenty healthy adults took selpercatinib under different conditions—with a high-fat meal, on an empty stomach, and after taking omeprazole. The goal was to see how fast the drug enters the bloodstream and how long it stays in the body, helping 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
Selpercatinib (cancer drug) and omeprazole (heartburn drug)
What this could lead to
If successful, this study could help doctors understand how to take selpercatinib with or without food and heartburn medication for best absorption.
What could go wrong
This is a small, early-stage study in healthy people, not patients. Results may not apply to those with cancer or other conditions.

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

20 people

The number who actually took part.

Started

May 2018

Finished

Sep 2018

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: * Non-vasectomized, male participants must have agreed to use a condom with spermicide or abstain from sexual intercourse during the study until 6 months after the last dosing. (No restrictions were required for a vasectomized male provided his vasectomy had been performed 4 months or more prior to the first dosing of study drug) * If male, must have agreed not to donate sperm from the first dosing until 6 months after the last dosing * Female participants of non-childbearing potential who are agreeable to take birth control measures until study completion * Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meter squared (kg/m²) and had a minimum weight of at least 50 kg at screening * Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study Exclusion Criteria: * Had a history of gastritis, gastrointestinal tract or hepatic disorder or other clinical condition that might have, in the opinion of the Principal Investigator or designee, and as confirmed by the Sponsor, affected the absorption, distribution, biotransformation, or excretion of LOXO 292 or omeprazole

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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

  • Celerion

    Tempe, Arizona, 85283, United States

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