A Study of Abemaciclib in Participants With Varying Degrees of Liver Impairment

Study Overview
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Brief Summary
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The study involves a single dose of a study drug called abemaciclib taken by mouth. The purpose of this study will be to measure how much study drug gets into the blood stream and how long the body takes to get rid of it when given to participants with mild, moderate, or severe liver impairment compared to healthy participants. In addition, the tolerability of the study drug will be evaluated. This study will last approximately 3 weeks for each participant, including check-in and follow-up.

Official Title
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A Single-Dose Pharmacokinetic Study of Abemaciclib (LY2835219) in Subjects With Varying Degrees of Hepatic Impairment

Conditions
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Hepatic Insufficiency

Intervention / Treatment
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* Drug: Abemaciclib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female participants must be of non-child-bearing potential Have a body mass index of 18 to 40 kilograms per square meter (kg/m²) Exclusion Criteria: No history of cardiovascular, renal, respiratory, gastrointestinal, endocrine or hematological disorders Have known allergies to abemaciclib, related compounds, or any components of the formulation No human immunodeficiency virus (HIV) infection or antibodies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abemaciclib: Normal Hepatic Function<br>Single dose of Abemaciclib administered orally on Day 1 to participants with normal hepatic function. | Drug: Abemaciclib<br>* Administered Orally<br>* Other names: LY2835219;|
| Experimental: Abemaciclib: Mild Hepatic Impairment<br>Single dose of Abemaciclib administered orally on Day 1 to participants with mild hepatic impairment. | Drug: Abemaciclib<br>* Administered Orally<br>* Other names: LY2835219;|
| Experimental: Abemaciclib: Moderate Hepatic Impairment<br>Single dose of Abemaciclib administered orally on Day 1 to participants with moderate hepatic impairment. | Drug: Abemaciclib<br>* Administered Orally<br>* Other names: LY2835219;|
| Experimental: Abemaciclib: Severe Hepatic Impairment<br>Single dose of Abemaciclib administered orally on Day 1 to participants with severe hepatic impairment. | Drug: Abemaciclib<br>* Administered Orally<br>* Other names: LY2835219;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Abemaciclib and Active Metabolites |  | Day 1: Predose, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose | 
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity(AUC[0-inf]) of Abemaciclib and Active Metabolites |  | Day 1: Predose, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose |