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NCT01821066 · ClinicalTrials.gov registry record · Phase 1
A Study To Determine If Coadministration Of Tamoxifen Alters The Extent Or Rate Of Palbociclib (PD-0332991) Absorption Or Elimination In Healthy Male Volunteers
A Phase 1 study of Healthy, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT01821066: Completed Phase 1 study of Healthy, sponsored by Pfizer.
NCT01821066 is a Phase 1 study of Healthy that has completed, run by Pfizer. The registered enrollment target is 25 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
NCT01821066, a Phase 1 study of Healthy, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
A single 125 mg oral dose of the investigational compound PD-0332991 will be administered alone and after steady-state dosing of tamoxifen to determine if coadministration of tamoxifen alters the plasma pharmacokinetics of PD-0332991 in healthy male volunteers.
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 PD-0332991 alone
- DRUG Tamoxifen 60 mg
- DRUG Tamoxifen 20 mg
- DRUG PD-0332991 combination
Study Locations (1)
Connecticut
- Pfizer Investigational Site - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2013-04 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
What the finished NCT01821066 record still lists
NCT01821066 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 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 4 interventions - of which PD-0332991 alone is the first listed.
NCT01821066 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT01821066 about?
NCT01821066 is a clinical study titled "A Study To Determine If Coadministration Of Tamoxifen Alters The Extent Or Rate Of Palbociclib (PD-0332991) Absorption Or Elimination In Healthy Male Volunteers". A single 125 mg oral dose of the investigational compound PD-0332991 will be administered alone and after steady-state dosing of tamoxifen to determine if coadministration of tamoxifen alters the plasma pharmacokinetics of PD-0332991 in healthy male volunteers.
What is the current status of trial NCT01821066?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2013-04. Estimated completion is 2013-08.
What conditions does trial NCT01821066 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01821066?
The interventions under investigation include: PD-0332991 alone (DRUG), Tamoxifen 60 mg (DRUG), Tamoxifen 20 mg (DRUG), PD-0332991 combination (DRUG).
Who is sponsoring clinical trial NCT01821066?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01821066 being conducted?
This trial has 1 study location across Connecticut. 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 NCT01821066's enrollment target sits among peer trials
25 778th of 1090 higher than 301 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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