At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Determine the Exposure-Response Relationship Between Abemaciclib and QT Interval in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Abemaciclib, Placebo, and 1 other intervention for Healthy. Completed, enrolled 35 participants across 2 sites.
Detailed Summary
The purposes of this study are to determine: * The effect of single increasing doses of the study drug, abemaciclib, on healthy participants. * The relationship between the amount of abemaciclib and the electrical tracing of the heart rhythm when abemaciclib is given. * How much abemaciclib is found in the bloodstream and how long the body takes to get rid of it. Information about any side effects that occur will be collected. The study will enroll two groups (cohorts) of participants. Each group will complete 4 study periods. This study is expected to last about 3 months. Screening may occur up to 28 days prior to enrollment. All participants will undergo a follow-up assessment approximately 21 days after administration of their final dose of study drug.
Study Details
Timeline
Interventions
Administered orally
Administered orally
Administered orally