At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 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.
The Effect of Food on the Pharmacokinetics of the Proposed Commercial Formulation of Abemaciclib in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Abemaciclib for Healthy. Completed, enrolled 30 participants across 2 sites.
Detailed Summary
The purpose of this study is to evaluate the amount of abemaciclib that reaches the blood stream and how long the body takes to get rid of it when given with and without food. In addition, the safety and tolerability of the study drug will be evaluated. Information about any side effects that may occur will also be collected. The study will last about 43 days for each participant, not including screening.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJun 2015
First PostedJun 2015
Primary CompletionSep 2015
TodayJul 2026
First PostedJun 26, 2015
Enrollment StartJun 1, 2015
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.0 years ago
Interventions
Abemaciclibdrug
Administered orally