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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 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 28 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01904747
The ClinicalTrials.gov registry entry for NCT01904747 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Palbociclib administered Fasted is the first listed.
NCT01904747 reports 0 study locations.
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.
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