NCT02387814

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

January 22, 2019

Completed
Last Updated

March 5, 2019

Status Verified

February 1, 2019

Enrollment Period

5 months

First QC Date

March 9, 2015

Results QC Date

October 27, 2017

Last Update Submit

February 22, 2019

Conditions

Hepatic Insufficiency

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (4)

Abemaciclib: Normal Hepatic Function

EXPERIMENTAL

Single dose of Abemaciclib administered orally on Day 1 to participants with normal hepatic function.

Drug: Abemaciclib

Abemaciclib: Mild Hepatic Impairment

EXPERIMENTAL

Single dose of Abemaciclib administered orally on Day 1 to participants with mild hepatic impairment.

Drug: Abemaciclib

Abemaciclib: Moderate Hepatic Impairment

EXPERIMENTAL

Single dose of Abemaciclib administered orally on Day 1 to participants with moderate hepatic impairment.

Drug: Abemaciclib

Abemaciclib: Severe Hepatic Impairment

EXPERIMENTAL

Single dose of Abemaciclib administered orally on Day 1 to participants with severe hepatic impairment.

Drug: Abemaciclib

Interventions

AbemaciclibDRUG

Administered Orally

Also known as: LY2835219
Abemaciclib: Mild Hepatic ImpairmentAbemaciclib: Moderate Hepatic ImpairmentAbemaciclib: Normal Hepatic FunctionAbemaciclib: Severe Hepatic Impairment

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female participants must be of non-child-bearing potential
  • Have a body mass index of 18 to 40 kilograms per square meter (kg/m²)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

DaVita Clinical Research

Lakewood, Colorado, 80228, United States

Location

Clinical Pharmacology of Miami (CPMI)

Miami, Florida, 33014, United States

Location

Orlando Clinical Research Center (OCRC)

Orlando, Florida, 32809, United States

Location

Indiana University - Digestive and Liver Diseases

Indianapolis, Indiana, 46202, United States

Location

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

abemaciclib

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 13, 2015

Study Start

March 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

March 5, 2019

Results First Posted

January 22, 2019

Record last verified: 2019-02

Locations

US(5)