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

Completed · Phase 1

Conditions studied: Hepatic Insufficiency

In brief

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.

Key facts

Study ID

NCT02387814

Run by

Eli Lilly and Company

People needed

35

Starts

2015-03-01

Expected to finish

2015-08-01

Last updated by the study team

2019-03-05

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Female participants must be of non-child-bearing potential
• Have a body mass index of 18 to 40 kilograms per square meter (kg/m²)

You may not qualify if…

• 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

Where it is running

• DaVita Clinical Research — Lakewood, Colorado, United States
• Clinical Pharmacology of Miami (CPMI) — Miami, Florida, United States
• Orlando Clinical Research Center (OCRC) — Orlando, Florida, United States
• Indiana University - Digestive and Liver Diseases — Indianapolis, Indiana, United States
• DaVita Clinical Research — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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