At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 28 enrolled
Drug / intervention
Palbociclib 75 mg Capsuledrug
Likely dose
Palbociclib 75 mg Capsulefrom 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 Phase 1, Open-label, Single Dose, Parallel-cohort Study To Evaluate The Pharmacokinetics Of Palbociclib (Pd-0332991) In Subjects With Impaired Hepatic Function
In Brief
A Phase 1 clinical trial evaluating Palbociclib 75 mg Capsule for Healthy, Hepatic Insufficiency. Completed, enrolled 28 participants across 2 sites.
Detailed Summary
This is a phase 1 study to describe the plasma pharmacokinetics of a single oral 75mg dose of palbociclib administered to healthy volunteers, and subjects with mild, moderate, and severely impaired hepatic function.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy, Hepatic Insufficiency
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 2015
Enrollment StartMar 2015
Primary CompletionOct 2016
TodayJul 2026
First PostedJan 8, 2015
Enrollment StartMar 31, 2015
Primary CompletionOct 9, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.5 years ago
Interventions
Palbociclib 75 mg Capsuledrug
Single oral 75 mg dose of palbociclib followed by serial PK sampling up to 192 hours post-dose (up to 120 hours post-dose for the healthy volunteer cohort).