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

Lilly

Status and phase: Completed; Phase 1

Conditions: Hepatic Insufficiency

Treatments: Drug: Abemaciclib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02387814

15538

I3Y-MC-JPBV (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 4 patient groups

Abemaciclib: Normal Hepatic Function

Experimental group

Description:

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

Treatment:

Drug: Abemaciclib

Abemaciclib: Mild Hepatic Impairment

Experimental group

Description:

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

Treatment:

Drug: Abemaciclib

Abemaciclib: Moderate Hepatic Impairment

Experimental group

Description:

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

Treatment:

Drug: Abemaciclib

Abemaciclib: Severe Hepatic Impairment

Experimental group

Description:

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

Treatment:

Drug: Abemaciclib