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Completed

NCT Number: NCT05440344

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Inland Empire Liver Foundation, Rialto, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imlunestrant

Drug

Administered orally.

Other names: LY3484356

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Imlunestrant

    Time frame: 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: Cmax of Imlunestrant is reported.

  2. PK: Area Under the Concentration-time Curve From 0 to the Last Measurable Concentration (AUC[0-t]) of Imlunestrant

    Time frame: 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)

    AUC(0-t) of Imlunestrant is reported.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Pharmacokinetics of Imlunestrant in Participants With Hepatic Impairment

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 30, 2022
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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