Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Liver function may change how cancer drug imlunestrant works

NCT ID NCT05440344

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 1 study looked at how imlunestrant, an oral drug, enters the bloodstream and leaves the body in women with and without liver impairment. 27 female participants took a single dose, and researchers measured drug levels over time. The goal is to understand if liver problems affect drug processing, which could guide future dosing.

What this could mean

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

Active substance
Imlunestrant (oral drug)
What this could lead to
If successful, this study could help doctors decide the right dose of imlunestrant for patients with liver problems.
What could go wrong
This is a very early, small study (27 people) focused on drug levels, not on treating any disease. Results may not predict real-world outcomes.

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

27 people

The number who actually took part.

Started

Jul 2022

Finished

Feb 2024

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 years and older

Sex

Female participants only

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: All Participants: * Women not of childbearing potential may participate and include those who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, bilateral salpingectomy or tubal ligation), congenital anomaly such as mullerian agenesis; or postmenopausal * Are between the body mass index (BMI) of 18.0 and 42.0 kilograms per meter squared (kg/m²), inclusive, at screening Healthy Participants: \- Healthy females as determined by medical history, physical examination, and other screening procedures, with normal liver function Participants with Impaired Liver Function: * Females with chronic mild, moderate and severe liver impairment, assessed by Child-Pugh scoring * Have diagnosis of chronic hepatic impairment (\>6 months), with no clinically significant changes within 90 days prior to study drug administration. Exclusion Criteria: * Women of childbearing potential are excluded from the study. * Have known allergies to imlunestrant or related compounds * Have a history of alcoholism or drug/chemical abuse within 2 years prior to check-in * Have received blood products within 2 months prior to check-in * Have evidence of HIV infection and/or positive human HIV antibodies * Have used or intend to use medications that are strong inhibiters or inducers of cytochrome P450 (CYP)3A4 * Who smoke more than 10 cigarettes or use the equivalent tobacco, smoking-cessation products, nicotine-containing products, or e-cigarettes (nicotine and non-nicotine) per day. * Have a history or presence of cardiovascular (eg, symptomatic bradycardia with resting heart rate of \<60 beats per minute), respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Healthy are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Hepatic Insufficiency liver failure

As listed by the trial registrant

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

Contacts and locations

Locations

  • American Research Corporation at Texas Liver Institute

    San Antonio, Texas, 78215, United States

  • Inland Empire Liver Foundation

    Rialto, California, 92377, United States

  • Orlando Clinical Research Center

    Orlando, Florida, 32809, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.