Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02387814
Other study ID # 15538
Secondary ID I3Y-MC-JPBV
Status Completed
Phase Phase 1
First received
Last updated
Start date March 2015
Est. completion date August 2015

Study information

Verified date February 2019
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Abemaciclib
Administered Orally

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT04097704 - Pharmacogenetics Sampling of the CC-90007-CP-003 Study Cohort
Completed NCT02161224 - A Study to Investigate the Exposure and Safety and Tolerability of a Single Dose of FG-4592 in Subjects With Moderately Diminished Liver Function Compared to Those With Normal Liver Function Phase 1
Completed NCT00929032 - Liver Transplantation and Reticuloendothelial Clearance Capacity N/A
Completed NCT00509210 - Study of Telaprevir in Subjects With Hepatic Impairment Phase 1
Completed NCT02894385 - Effect of Hepatic and Renal Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1841788 (ODM-201) Phase 1
Completed NCT03306667 - Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency) Phase 1
Completed NCT04867941 - A Study to Evaluate the Effect of Hepatic Insufficiency on the Pharmacokinetics (PK) of ACP-196 Phase 1
Terminated NCT02457702 - Mitochondrial Function in Patients With Severe Liver Disease N/A
Completed NCT02090621 - Extracorporeal Photopheresis After Liver Transplant Phase 2
Completed NCT02249442 - Study to Determine the Pharmacokinetics on TPV/r in Subjects With Mild and Moderate Hepatic Insufficiency Phase 1
Completed NCT03341884 - A Study of Ipatasertib in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Participants Phase 1
Completed NCT01475136 - A Study of LY2140023 in Hepatically-Impaired Participants Phase 1
Completed NCT00968591 - Pharmacokinetics of Everolimus in Subjects With Hepatic Insufficiency Phase 1
Completed NCT00969813 - A Safety and Tolerability Study of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function Phase 1
Completed NCT00931060 - Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects N/A
Completed NCT00416702 - Safety and Pharmacokinetics of Indacaterol in Healthy Subjects and Those With Impaired Liver Function Phase 1
Completed NCT03968848 - Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite Phase 1
Completed NCT00692341 - Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics Phase 1
Completed NCT00314054 - Study Evaluating the Safety of HCV-796 in Subjects With Liver Disease and in Healthy Adults Phase 1
Completed NCT05731895 - A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Liver Problems Phase 1