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

J2J-MC-JZLG -

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. 

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Hepatic Insufficiency
What the trial is testing?
Imlunestrant (LY3484356)
Could I receive a Placebo?
No
Enrollment Goal
28
Trial Dates
Jul 5, 2022 - Feb 28, 2024
How long will I be in the trial?
Your participation could last up to 46 days.
Trial Phase
I

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participants must have a diagnosis of impaired liver function

  • All Participants: Female participants must be not of childbearing potential and are infertile due to surgical sterilization like hysterectomy,tubal ligation etc. or postmenopausal

  • All Participants: Participants must have a body mass index(BMI) between 18.0 and 42.0 kilograms per meter squared (kg/m2) at screening

  • Healthy Participants: Healthy females as determined by medical history, physical examination, and other screening procedures, with normal liver function

Participants Must Not:

  • Participants must not have any known allergies to imlunestrant or related compounds

  • Participants must not have a history of alcoholism or drug/chemical abuse within 2 years prior to screening

  • Participants must not have received blood products within 2 months prior to screening

  • Participants must not smoke more than ten cigarettes per day or use the equivalent amount of tobacco, smoking cessation products or e-cigarettes (nicotine and non-nicotine)

  • Participants must not have a history of or a diagnosis of heart, kidney, respiratory or gastrointestinal disease which can alert the absorption, metabolism, or elimination of drugs

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