A Study of Abemaciclib in Participants With Varying Degrees of Liver Impairment
- Registration Number
- NCT02387814
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- Female participants must be of non-child-bearing potential
- Have a body mass index of 18 to 40 kilograms per square meter (kg/m²)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Abemaciclib: Normal Hepatic Function Abemaciclib Single dose of Abemaciclib administered orally on Day 1 to participants with normal hepatic function. Abemaciclib: Mild Hepatic Impairment Abemaciclib Single dose of Abemaciclib administered orally on Day 1 to participants with mild hepatic impairment. Abemaciclib: Severe Hepatic Impairment Abemaciclib Single dose of Abemaciclib administered orally on Day 1 to participants with severe hepatic impairment. Abemaciclib: Moderate Hepatic Impairment Abemaciclib Single dose of Abemaciclib administered orally on Day 1 to participants with moderate hepatic impairment.
- Primary Outcome Measures
Name Time Method 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
DaVita Clinical Research
🇺🇸Minneapolis, Minnesota, United States
Orlando Clinical Research Center (OCRC)
🇺🇸Orlando, Florida, United States
Clinical Pharmacology of Miami (CPMI)
🇺🇸Miami, Florida, United States
Indiana University - Digestive and Liver Diseases
🇺🇸Indianapolis, Indiana, United States