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

Completed · Phase 1

Conditions studied: Hepatic Insufficiency, Healthy

In brief

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.

Key facts

Study ID

NCT05440344

Run by

Eli Lilly and Company

People needed

27

Starts

2022-07-05

Expected to finish

2024-02-28

Last updated by the study team

2025-11-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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