Liver function may change how cancer drug imlunestrant works
NCT ID NCT05440344
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
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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
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Female participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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American Research Corporation at Texas Liver Institute
San Antonio, Texas, 78215, United States
-
Inland Empire Liver Foundation
Rialto, California, 92377, United States
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Orlando Clinical Research Center
Orlando, Florida, 32809, United States
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