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NCT02334800 · ClinicalTrials.gov registry record · Phase 1
A Study To Describe The Effect Of Impaired Hepatic Function Of The Pharmacokinetics Of Palbociclib
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT02334800: Completed Phase 1 study, sponsored by Pfizer.
NCT02334800 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02334800, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study 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.
Primary Outcome
AUCinf is area under the plasma concentration time curve from time 0 extrapolated infinite time. It is calculated as AUClast + (Clast/kel), where AUClast is area under the concentration-time curve from time 0 to the time of the last quantifiable concentration, Clast is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentratio
Interventions
- DRUG Palbociclib 75 mg Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2015-03-31 |
| Est. Completion | 2016-10-09 |
| Phase | Phase 1 |
What the finished NCT02334800 record still lists
NCT02334800 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which Palbociclib 75 mg Capsule is the first listed.
NCT02334800 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02334800 about?
NCT02334800 is a clinical study titled "A Study To Describe The Effect Of Impaired Hepatic Function Of The Pharmacokinetics Of Palbociclib". 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.
What is the current status of trial NCT02334800?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2015-03-31. Estimated completion is 2016-10-09.
What interventions are being tested in trial NCT02334800?
The interventions under investigation include: Palbociclib 75 mg Capsule (DRUG).
Who is sponsoring clinical trial NCT02334800?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02334800's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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