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

Phase 1

Completed

• Conditions: Healthy; Hepatic Insufficiency
• Interventions: Drug: Imlunestrant

• Registration Number: NCT05440344
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-06-30
• Study Start: 2022-07-05
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Imlunestrant (Mild Hepatic Impairment)	Imlunestrant	Imlunestrant administered orally.
Imlunestrant (Severe Hepatic Impairment)	Imlunestrant	Imlunestrant administered orally.
Imlunestrant (Normal Hepatic Function)	Imlunestrant	Imlunestrant administered orally.
Imlunestrant (Moderate Hepatic Impairment)	Imlunestrant	Imlunestrant administered orally.

Primary Outcome Measures

Name	Time	Method
PK: Area Under the Concentration Versus Time Curve (AUC) of Imlunestrant	Pre-dose up to 240 hours post-dose	PK: AUC of Imlunestrant
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Imlunestrant	Pre-dose up to 240 hours post-dose	PK: Cmax of Imlunestrant

Trial Locations

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