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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05440344
Collaborator
(none)
42
Enrollment
3
Locations
4
Arms
7.4
Anticipated Duration (Months)
14
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Pharmacokinetics of Imlunestrant in Participants With Hepatic Impairment
Actual Study Start Date :
Jul 5, 2022
Anticipated Primary Completion Date :
Feb 14, 2023
Anticipated Study Completion Date :
Feb 14, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Imlunestrant (Mild Hepatic Impairment)

Imlunestrant administered orally.

Drug: Imlunestrant
Administered orally.
Other Names:
  • LY3484356

    		•
    Experimental: Imlunestrant (Moderate Hepatic Impairment)

    Imlunestrant administered orally.

    Drug: Imlunestrant
    Administered orally.
    Other Names:
  • LY3484356

    		•
    Experimental: Imlunestrant (Severe Hepatic Impairment)

    Imlunestrant administered orally.

    Drug: Imlunestrant
    Administered orally.
    Other Names:
  • LY3484356

    		•
    Experimental: Imlunestrant (Normal Hepatic Function)

    Imlunestrant administered orally.

    Drug: Imlunestrant
    Administered orally.
    Other Names:
  • LY3484356

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Imlunestrant [Pre-dose up to 240 hours post-dose]

      PK: Cmax of Imlunestrant

    2. PK: Area Under the Concentration Versus Time Curve (AUC) of Imlunestrant [Pre-dose up to 240 hours post-dose]

      PK: AUC of Imlunestrant

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: 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), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05440344
    Other Study ID Numbers:
    • 18414
    • J2J-MC-JZLG
    First Posted:
    Jun 30, 2022
    Last Update Posted:
    Jul 11, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hepatic Insufficiency
    Liver Failure

    Study Results

    No Results Posted as of Jul 11, 2022