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NCT02059330 · ClinicalTrials.gov registry record · Phase 1
A Study To Investigate Palbociclib (PD-0332991) Pharmacokinetics In Healthy Subjects Of Japanese Descent Relative To Healthy Non-Asian Subjects, And To Determine If Changes In Palbociclib Dose Result In Proportional Changes In Palbociclib Plasma Exposure In Japanese Subjects
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT02059330 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 27 participants.
The verdict
NCT02059330, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
This study will investigate the dose-proportionality of palbociclib pharmacokinetics in healthy subjects of Japanese descent. Approximately fourteen healthy Japanese subjects will receive four single doses of palbociclib (PD-0332991) with a minimum washout of 10 days between doses. Additionally, this study will investigate the effect of Japanese ethnicity of palbociclib pharmacokinetics by comparing palbociclib pharmacokinetics at a single dose-level between healthy subjects of Japanese descent and approximately fourteen healthy non-Asian subjects.
Interventions
- DRUG Palbociclib
- DRUG Palbociclib 125mg
- DRUG Palbociclib 75mg
- DRUG Palbociclib 100mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2014-03 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02059330
The ClinicalTrials.gov registry entry for NCT02059330 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 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 is the first listed.
NCT02059330 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02059330 about?
NCT02059330 is a clinical study titled "A Study To Investigate Palbociclib (PD-0332991) Pharmacokinetics In Healthy Subjects Of Japanese Descent Relative To Healthy Non-Asian Subjects, And To Determine If Changes In Palbociclib Dose Result In Proportional Changes In Palbociclib Plasma Exposure In Japanese Subjects". This study will investigate the dose-proportionality of palbociclib pharmacokinetics in healthy subjects of Japanese descent. Approximately fourteen healthy Japanese subjects will receive four single doses of palbociclib (PD-0332991) with a minimum washout of 10 days between doses. Additionally, thi...
What is the current status of trial NCT02059330?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2014-03. Estimated completion is 2014-06.
What interventions are being tested in trial NCT02059330?
The interventions under investigation include: Palbociclib (DRUG), Palbociclib 125mg (DRUG), Palbociclib 75mg (DRUG), Palbociclib 100mg (DRUG).
Who is sponsoring clinical trial NCT02059330?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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