Hepatic Insufficiency Clinical Trial
Official title:
A Single-Dose Pharmacokinetic Study of Abemaciclib (LY2835219) in Subjects With Varying Degrees of Hepatic Impairment
| Verified date | February 2019 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 35 |
| Est. completion date | August 2015 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Indiana University - Digestive and Liver Diseases | Indianapolis | Indiana |
| United States | DaVita Clinical Research | Lakewood | Colorado |
| United States | Clinical Pharmacology of Miami (CPMI) | Miami | Florida |
| United States | DaVita Clinical Research | Minneapolis | Minnesota |
| United States | Orlando Clinical Research Center (OCRC) | Orlando | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | ||
| Primary | 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 |
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