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NCT01918176 · ClinicalTrials.gov registry record · Phase 1
Drug Interaction Study To Investigate The Potential Effect Of Proton Pump Inhibitor On The Pharmacokinetics Of Palbociclib (PD-0332991)
A Phase 1 study of Healthy, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT01918176: Completed Phase 1 study of Healthy, sponsored by Pfizer.
NCT01918176 is a Phase 1 study of Healthy that has completed, run by Pfizer. The registered enrollment target is 26 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01918176, a Phase 1 study of Healthy, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
Fixed sequence, 2-period crossover study to compare the pharmacokinetic profiles of Palbociclib in absence and presence of prior administration of proton pump inhibitor Rabeprazole. The increased gastric pH achieved by the treatment with multiple doses of Rabeprazole might affect the absorption process of Palbociclib.
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).
Conditions Studied
Interventions
- DRUG Palbociclib alone
- DRUG Palbociclib + Rabeprazole
Study Locations (1)
Florida
- Pfizer Investigational Site - South Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2013-09 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
What the finished NCT01918176 record still lists
NCT01918176 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Palbociclib alone is the first listed.
NCT01918176 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01918176 about?
NCT01918176 is a clinical study titled "Drug Interaction Study To Investigate The Potential Effect Of Proton Pump Inhibitor On The Pharmacokinetics Of Palbociclib (PD-0332991)". Fixed sequence, 2-period crossover study to compare the pharmacokinetic profiles of Palbociclib in absence and presence of prior administration of proton pump inhibitor Rabeprazole. The increased gastric pH achieved by the treatment with multiple doses of Rabeprazole might affect the absorption proc...
What is the current status of trial NCT01918176?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2013-09. Estimated completion is 2013-12.
What conditions does trial NCT01918176 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01918176?
The interventions under investigation include: Palbociclib alone (DRUG), Palbociclib + Rabeprazole (DRUG).
Who is sponsoring clinical trial NCT01918176?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01918176 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01918176's enrollment target sits among peer trials
26 760th of 1090 higher than 314 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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