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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05440344
Recruitment Status : Recruiting
First Posted : June 30, 2022
Last Update Posted : July 11, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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
Hepatic Insufficiency Healthy Drug: Imlunestrant Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 5, 2022
Estimated Primary Completion Date : February 14, 2023
Estimated Study Completion Date : February 14, 2023

Arm Intervention/treatment
Experimental: Imlunestrant (Mild Hepatic Impairment)
Imlunestrant administered orally.
Drug: Imlunestrant
Administered orally.
Other Name: LY3484356

Experimental: Imlunestrant (Moderate Hepatic Impairment)
Imlunestrant administered orally.
Drug: Imlunestrant
Administered orally.
Other Name: LY3484356

Experimental: Imlunestrant (Severe Hepatic Impairment)
Imlunestrant administered orally.
Drug: Imlunestrant
Administered orally.
Other Name: LY3484356

Experimental: Imlunestrant (Normal Hepatic Function)
Imlunestrant administered orally.
Drug: Imlunestrant
Administered orally.
Other Name: LY3484356




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

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05440344


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@Lilly.com

Locations
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United States, California
Inland Empire Liver Foundation Recruiting
Rialto, California, United States, 92377
Contact    909-586-6286      
Principal Investigator: Zeid Kayali         
United States, Florida
Orlando Clinical Research Center Recruiting
Orlando, Florida, United States, 32809
Principal Investigator: Thomas C Marbury         
United States, Texas
American Research Corporation at Texas Liver Institute Recruiting
San Antonio, Texas, United States, 78215
Principal Investigator: Eric J. Lawitz         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05440344    
Other Study ID Numbers: 18414
J2J-MC-JZLG ( Other Identifier: Eli Lilly and Company )
First Posted: June 30, 2022    Key Record Dates
Last Update Posted: July 11, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatic Insufficiency
Liver Failure
Liver Diseases
Digestive System Diseases