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

Healthy Clinical Trial

Official title:

Pharmacokinetics of Imlunestrant in Participants With Hepatic Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05440344
• Other study ID #: 18414
• Secondary ID: J2J-MC-JZLG
• Status: Completed
• Phase: Phase 1
• Start date: July 5, 2022
• Est. completion date: February 28, 2024

Study information

• Verified date: March 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Hepatic Insufficiency
• Liver Failure

Intervention

Drug:
• Imlunestrant
Administered orally.

Locations

Country	Name	City	State
United States	Orlando Clinical Research Center	Orlando	Florida
United States	Inland Empire Liver Foundation	Rialto	California
United States	American Research Corporation at Texas Liver Institute	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Imlunestrant	PK: Cmax of Imlunestrant	Pre-dose up to 240 hours post-dose
Primary	PK: Area Under the Concentration Versus Time Curve (AUC) of Imlunestrant	PK: AUC of Imlunestrant	Pre-dose up to 240 hours post-dose

External Links

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