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

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Insufficiency
• Intervention / Treatment: Drug: Abemaciclib

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Davita Clinical Research
  • Florida
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology of Miami (CPMI)
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center (OCRC)
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University - Digestive and Liver Diseases
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Davita Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Abemaciclib: Normal Hepatic Function; Single dose of Abemaciclib administered orally on Day 1 to participants with normal hepatic function.	Drug: Abemaciclib; Administered Orally; Other Names: LY2835219
EXPERIMENTAL: Abemaciclib: Mild Hepatic Impairment; Single dose of Abemaciclib administered orally on Day 1 to participants with mild hepatic impairment.	Drug: Abemaciclib; Administered Orally; Other Names: LY2835219
EXPERIMENTAL: Abemaciclib: Moderate Hepatic Impairment; Single dose of Abemaciclib administered orally on Day 1 to participants with moderate hepatic impairment.	Drug: Abemaciclib; Administered Orally; Other Names: LY2835219
EXPERIMENTAL: Abemaciclib: Severe Hepatic Impairment; Single dose of Abemaciclib administered orally on Day 1 to participants with severe hepatic impairment.	Drug: Abemaciclib; Administered Orally; Other Names: LY2835219

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: March 9, 2015
• First Submitted That Met QC Criteria: March 9, 2015
• First Posted (ESTIMATE): March 13, 2015

Study Record Updates

• Last Update Posted (ACTUAL): March 5, 2019
• Last Update Submitted That Met QC Criteria: February 22, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency
• Other Study ID Numbers: 15538; I3Y-MC-JPBV (OTHER: Eli Lilly and Company)