A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function
NCT ID: NCT05440344
Last Updated: 2025-11-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2022-07-05
2024-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Imlunestrant (Normal Hepatic Function)
Participants received a single dose of Imlunestrant 400 milligrams (mg) administered orally on Day 1 in fasted state.
Imlunestrant
Administered orally.
Imlunestrant (Mild Hepatic Impairment)
Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
Imlunestrant
Administered orally.
Imlunestrant (Moderate Hepatic Impairment)
Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
Imlunestrant
Administered orally.
Imlunestrant (Severe Hepatic Impairment)
Participants received a single dose of Imlunestrant 200 mg administered orally on Day 1 in fasted state.
Imlunestrant
Administered orally.
Interventions
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Imlunestrant
Administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function
Other Identifiers
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J2J-MC-JZLG
Identifier Type: OTHER
Identifier Source: secondary_id
18414
Identifier Type: -
Identifier Source: org_study_id