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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-08-31

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.

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Detailed Description

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Conditions

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Hepatic Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Abemaciclib: Normal Hepatic Function

Single dose of Abemaciclib administered orally on Day 1 to participants with normal hepatic function.

Group Type EXPERIMENTAL

Abemaciclib

Intervention Type DRUG

Administered Orally

Abemaciclib: Mild Hepatic Impairment

Single dose of Abemaciclib administered orally on Day 1 to participants with mild hepatic impairment.

Group Type EXPERIMENTAL

Abemaciclib

Intervention Type DRUG

Administered Orally

Abemaciclib: Moderate Hepatic Impairment

Single dose of Abemaciclib administered orally on Day 1 to participants with moderate hepatic impairment.

Group Type EXPERIMENTAL

Abemaciclib

Intervention Type DRUG

Administered Orally

Abemaciclib: Severe Hepatic Impairment

Single dose of Abemaciclib administered orally on Day 1 to participants with severe hepatic impairment.

Group Type EXPERIMENTAL

Abemaciclib

Intervention Type DRUG

Administered Orally

Interventions

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Abemaciclib

Administered Orally

Intervention Type DRUG

Other Intervention Names

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LY2835219

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes