Clinical trial NCT05440344: A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function
Official title: Pharmacokinetics of Imlunestrant in Participants With Hepatic Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Insufficiency
Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-06-30
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Imlunestrant
timeFrame: Pre-dose up to 240 hours post-dose
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of Imlunestrant
timeFrame: Pre-dose up to 240 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: San Antonio
country: United States
facility: American Research Corporation at Texas Liver Institute
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: