Phase 1 Completed N=35 Basic Science

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

Hepatic Insufficiency

Source: ClinicalTrials.gov NCT02387814 ↗

Enrolled (actual)

Serious AEs

2.9%

Results posted

Jan 2019

Primary outcomePrimary: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Abemaciclib and Active Metabolites — 133; 109; 83.9; 156 nanograms per milliliter (ng/mL)

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Abemaciclib and Active Metabolites	133; 109; 83.9; 156; 31.2; 26.0	—
PRIMARY Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity(AUC[0-inf]) of Abemaciclib and Active Metabolites	4460; 4280; 4940; 9310; 1420; 1090	—

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

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Data sourced from ClinicalTrials.gov (NCT02387814). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.