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COMPLETEDPHASE1

A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function

Pharmacokinetics of Imlunestrant in Participants With Hepatic Impairment

NCT05440344•Eli Lilly and Company

Summary

The main purpose of this study is to measure how much of Imlunestrant (LY3484356) gets into the bloodstream and how long it takes the body to eliminate it in female participants with impaired liver function compared to female participants with normal liver function. The side effects and tolerability of Imlunestrant will also be evaluated. The study may last up to 46 days for each participant.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

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

Locations (3)

Inland Empire Liver Foundation

Rialto, California, United States

Orlando Clinical Research Center

Orlando, Florida, United States

American Research Corporation at Texas Liver Institute

San Antonio, Texas, United States

Key Dates

Start Date

July 5, 2022

Primary Completion Date

February 28, 2024

Completion Date

February 28, 2024

Last Updated

November 12, 2025

Enrollment

ACTUAL participants

Conditions

Hepatic InsufficiencyHealthy

Interventions

Imlunestrant

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function

Inclusion Criteria

Exclusion Criteria

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