At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 35 enrolled
Drug / intervention
Abemaciclibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-Dose Pharmacokinetic Study of Abemaciclib (LY2835219) in Subjects With Varying Degrees of Hepatic Impairment
In Brief
A Phase 1 clinical trial evaluating Abemaciclib for Hepatic Insufficiency. Completed, enrolled 35 participants across 5 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Insufficiency
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartMar 2015
First PostedMar 2015
Primary CompletionAug 2015
TodayJul 2026
First PostedMar 13, 2015
Enrollment StartMar 1, 2015
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 11.3 years ago
Interventions
Abemaciclibdrug
Administered Orally