Back to resultsA Study of Abemaciclib in Participants With Varying Degrees of Liver Impairment
Primary Purpose
Hepatic Insufficiency
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Abemaciclib
Sponsored by
About this trial
This is an interventional basic science trial for Hepatic Insufficiency
Eligibility Criteria
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
Sites / Locations
- DaVita Clinical Research
- Clinical Pharmacology of Miami (CPMI)
- Orlando Clinical Research Center (OCRC)
- Indiana University - Digestive and Liver Diseases
- DaVita Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Abemaciclib: Normal Hepatic Function
Abemaciclib: Mild Hepatic Impairment
Abemaciclib: Moderate Hepatic Impairment
Abemaciclib: Severe Hepatic Impairment
Arm Description
Single dose of Abemaciclib administered orally on Day 1 to participants with normal hepatic function.
Single dose of Abemaciclib administered orally on Day 1 to participants with mild hepatic impairment.
Single dose of Abemaciclib administered orally on Day 1 to participants with moderate hepatic impairment.
Single dose of Abemaciclib administered orally on Day 1 to participants with severe hepatic impairment.
Outcomes
Primary Outcome Measures
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Abemaciclib and Active Metabolites
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity(AUC[0-inf]) of Abemaciclib and Active Metabolites
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02387814
Brief Title
A Study of Abemaciclib in Participants With Varying Degrees of Liver Impairment
Official Title
A Single-Dose Pharmacokinetic Study of Abemaciclib (LY2835219) in Subjects With Varying Degrees of Hepatic Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Insufficiency
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abemaciclib: Normal Hepatic Function
Arm Type
Experimental
Arm Description
Single dose of Abemaciclib administered orally on Day 1 to participants with normal hepatic function.
Arm Title
Abemaciclib: Mild Hepatic Impairment
Arm Type
Experimental
Arm Description
Single dose of Abemaciclib administered orally on Day 1 to participants with mild hepatic impairment.
Arm Title
Abemaciclib: Moderate Hepatic Impairment
Arm Type
Experimental
Arm Description
Single dose of Abemaciclib administered orally on Day 1 to participants with moderate hepatic impairment.
Arm Title
Abemaciclib: Severe Hepatic Impairment
Arm Type
Experimental
Arm Description
Single dose of Abemaciclib administered orally on Day 1 to participants with severe hepatic impairment.
Intervention Type
Drug
Intervention Name(s)
Abemaciclib
Other Intervention Name(s)
LY2835219
Intervention Description
Administered Orally
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Abemaciclib and Active Metabolites
Time Frame
Day 1: Predose, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose
Title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity(AUC[0-inf]) of Abemaciclib and Active Metabolites
Time Frame
Day 1: Predose, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
DaVita Clinical Research
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Clinical Pharmacology of Miami (CPMI)
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Orlando Clinical Research Center (OCRC)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Indiana University - Digestive and Liver Diseases
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
DaVita Clinical Research
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Abemaciclib in Participants With Varying Degrees of Liver Impairment
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