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NCT01904747 · ClinicalTrials.gov registry record · Phase 1
Characterization Of The Effect Of Food On Palbociclib (PD-0332991) Absorption
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT01904747: Completed Phase 1 study, sponsored by Pfizer.
NCT01904747 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
NCT01904747, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This study is intended to quantify the effect of food on the extent of absorption of palbociclib. The caloric content of the food and the time of the meals with respect to palbociclib administration may influence the capacity of the body to absorb the drug. High and low calorie meals will be given to the subjects 30 minutes before palbociclib administration as 2 of the 3 conditions to compare with completely absence of food in the body when dosing (fasted).The third condition to test and compare with fasted stage will be the administration of food before and after palbociclib administration. This information will help the program to decide wether or not the presence of food when dosing palbociclib help with its absorption and to what extent it does help. Based on the collected information, a recommendation about the administration of palbociclib with food will be provided to patients.
Primary Outcome
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Interventions
- DRUG Palbociclib administered Fasted
- DRUG Palbociclib administered Fed high calorie
- DRUG Palbociclib administered Fed low calorie
- DRUG Palbociclib administered Fed moderate calorie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2013-07 |
| Est. Completion | 2013-10 |
| Phase | Phase 1 |
What the finished NCT01904747 record still lists
NCT01904747 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 4 interventions - of which Palbociclib administered Fasted is the first listed.
NCT01904747 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01904747 about?
NCT01904747 is a clinical study titled "Characterization Of The Effect Of Food On Palbociclib (PD-0332991) Absorption". This study is intended to quantify the effect of food on the extent of absorption of palbociclib. The caloric content of the food and the time of the meals with respect to palbociclib administration may influence the capacity of the body to absorb the drug. High and low calorie meals will be given...
What is the current status of trial NCT01904747?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2013-07. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01904747?
The interventions under investigation include: Palbociclib administered Fasted (DRUG), Palbociclib administered Fed high calorie (DRUG), Palbociclib administered Fed low calorie (DRUG), Palbociclib administered Fed moderate calorie (DRUG).
Who is sponsoring clinical trial NCT01904747?
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 NCT01904747'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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