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Hormone Therapy

Imlunestrant for Liver Failure

Phase 1
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose up to 240 hours post-dose
Awards & highlights

Study Summary

This trial is testing a new drug to see how well it works and if it is safe for women with impaired liver function.

Who is the study for?
This trial is for women who cannot have children due to surgery, congenital conditions, or being postmenopausal. Participants should have a BMI of 18-42 and can either be healthy with normal liver function or have chronic mild to severe liver impairment. Women must not have had significant health changes in the last 90 days, no drug abuse history within two years, and no blood transfusions in the past two months.Check my eligibility
What is being tested?
The study tests how female participants with different levels of liver function process Imlunestrant (LY3484356). It compares how much drug gets into the bloodstream and its elimination rate between those with impaired and normal liver functions over up to 46 days.See study design
What are the potential side effects?
While specific side effects are not listed here, this trial will monitor how well participants tolerate Imlunestrant and any adverse reactions they experience during the study period.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose up to 240 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose up to 240 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PK: Area Under the Concentration Versus Time Curve (AUC) of Imlunestrant
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Imlunestrant

Trial Design

4Treatment groups
Experimental Treatment
Group I: Imlunestrant (Severe Hepatic Impairment)Experimental Treatment1 Intervention
Imlunestrant administered orally.
Group II: Imlunestrant (Normal Hepatic Function)Experimental Treatment1 Intervention
Imlunestrant administered orally.
Group III: Imlunestrant (Moderate Hepatic Impairment)Experimental Treatment1 Intervention
Imlunestrant administered orally.
Group IV: Imlunestrant (Mild Hepatic Impairment)Experimental Treatment1 Intervention
Imlunestrant administered orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imlunestrant
2022
Completed Phase 1
~170

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,615 Previous Clinical Trials
3,201,030 Total Patients Enrolled
9 Trials studying Liver Failure
293 Patients Enrolled for Liver Failure
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
405,224 Total Patients Enrolled
8 Trials studying Liver Failure
257 Patients Enrolled for Liver Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals still signing up for this research endeavor?

"This clinical trial is currently in the process of recruiting participants, based on information provided by clinicaltrials.gov. This medical research was first published on July 5th 2022 and recently updated on November 22nd 2022."

Answered by AI

What is the safety profile for Imlunestrant?

"Imlunestrant has only been subjected to preliminary testing, so it earns a score of 1 for safety. This means there is limited evidence underlying its efficacy and security."

Answered by AI

What is the extent of the cohort being observed in this research?

"To begin the trial, 42 individuals that meet this clinical study's criteria must be recruited. Eli Lilly & Co., the project sponsor, will manage recruitment from Orlando Clinical Research Center in Florida and American Research Corporation at Texas Liver Institute in Texas."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
Florida
How old are they?
18 - 65
What site did they apply to?
Inland Empire Liver Foundation
Orlando Clinical Research Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I wanted to see if I could be a good fit for the study and make a change in my life.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function
2022. "A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05440344.
~10 spots leftby Apr 2025
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