A Study of Abemaciclib in Participants With Varying Degrees of Liver Impairment
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 3/7/2019 |
| Start Date: | March 2015 |
| End Date: | August 2015 |
A Single-Dose Pharmacokinetic Study of Abemaciclib (LY2835219) in Subjects With Varying Degrees of Hepatic Impairment
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.
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.
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
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