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

Pharmacokinetics of Imlunestrant in Participants With Hepatic Impairment

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Insufficiency; Healthy
• Intervention / Treatment: Drug: Imlunestrant

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Rialto, California, United States, 92377
      • Inland Empire Liver Foundation
  • Florida
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center
  • Texas
    • San Antonio, Texas, United States, 78215
      • American Research Corporation at Texas Liver Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imlunestrant (Normal Hepatic Function); Participants received a single dose of Imlunestrant 400 milligrams (mg) administered orally on Day 1 in fasted state.	Drug: Imlunestrant; Administered orally.; Other Names: LY3484356
Experimental: Imlunestrant (Mild Hepatic Impairment); Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.	Drug: Imlunestrant; Administered orally.; Other Names: LY3484356
Experimental: Imlunestrant (Moderate Hepatic Impairment); Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.	Drug: Imlunestrant; Administered orally.; Other Names: LY3484356
Experimental: Imlunestrant (Severe Hepatic Impairment); Participants received a single dose of Imlunestrant 200 mg administered orally on Day 1 in fasted state.	Drug: Imlunestrant; Administered orally.; Other Names: LY3484356

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Imlunestrant	PK: Cmax of Imlunestrant is reported.	Day 1 (Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post dose)
PK: Area Under the Concentration-time Curve From 0 to the Last Measurable Concentration (AUC[0-t]) of Imlunestrant	AUC(0-t) of Imlunestrant is reported.	Day 1 (Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post dose)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2022
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): November 12, 2025
• Last Update Submitted That Met QC Criteria: October 22, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Hepatic Insufficiency; Imlunestrant
• Other Study ID Numbers: 18414; J2J-MC-JZLG (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No