Status:
COMPLETED
A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function
Lead Sponsor:
Eli Lilly and Company
Conditions:
Hepatic Insufficiency
Healthy
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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 fu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2024
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT05440344
Start Date
July 5 2022
End Date
February 28 2024
Last Update
November 12 2025
Active Locations (3)
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1
Inland Empire Liver Foundation
Rialto, California, United States, 92377
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
3
American Research Corporation at Texas Liver Institute
San Antonio, Texas, United States, 78215