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

Last updated: March 28, 2024
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

1

Condition

Primary Biliary Cholangitis

Liver Failure

Liver Disease

Treatment

Imlunestrant

Clinical Study ID

NCT05440344
18414
J2J-MC-JZLG
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: All Participants:

  • Women not of childbearing potential may participate and include those who areinfertile due to surgical sterilization (hysterectomy, bilateral oophorectomy,bilateral salpingectomy or tubal ligation), congenital anomaly such as mullerianagenesis; 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 otherscreening procedures, with normal liver function Participants with Impaired Liver Function:

  • Females with chronic mild, moderate and severe liver impairment, assessed byChild-Pugh scoring

  • Have diagnosis of chronic hepatic impairment (>6 months), with no clinicallysignificant changes within 90 days prior to study drug administration.

Exclusion

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 ofcytochrome P450 (CYP)3A4
  • Who smoke more than 10 cigarettes or use the equivalent tobacco, smoking-cessationproducts, nicotine-containing products, or e-cigarettes (nicotine and non-nicotine)per day.
  • Have a history or presence of cardiovascular (eg, symptomatic bradycardia with restingheart rate of <60 beats per minute), respiratory, renal, gastrointestinal, endocrine,hematological, or neurological disorders capable of significantly altering theabsorption, metabolism, or elimination of drugs

Study Design

Total Participants: 28
Treatment Group(s): 1
Primary Treatment: Imlunestrant
Phase: 1
Study Start date:
July 05, 2022
Estimated Completion Date:
February 28, 2024

Connect with a study center

  • Inland Empire Liver Foundation

    Rialto, California 92377
    United States

    Site Not Available

  • Orlando Clinical Research Center

    Orlando, Florida 32809
    United States

    Site Not Available

  • American Research Corporation at Texas Liver Institute

    San Antonio, Texas 78215
    United States

    Site Not Available

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