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NCT01603264 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic Study Comparing PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-01)
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 105
- Enrollment target
NCT01603264: Completed Phase 1 study, sponsored by Pfizer.
NCT01603264 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 105 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01603264, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 105 participants
- Enrollment target
Study Summary
In this study, healthy male volunteers will receive a single intravenous administration of either PF-05280014 or trastuzumab (United States) or trastuzumab (European Union). During the course of the study, the pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms of PF-05280014 and the US-licensed and EU-approved trastuzumab products. Safety, tolerability, and immunologic response also will be evaluated throughout.
Interventions
- BIOLOGICAL PF-05280014
- BIOLOGICAL Herceptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2012-05 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
What the finished NCT01603264 record still lists
NCT01603264 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% higher).
The record links to 0 conditions, and to 2 interventions - of which PF-05280014 is the first listed.
NCT01603264 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01603264 about?
NCT01603264 is a clinical study titled "A Pharmacokinetic Study Comparing PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-01)". In this study, healthy male volunteers will receive a single intravenous administration of either PF-05280014 or trastuzumab (United States) or trastuzumab (European Union). During the course of the study, the pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comp...
What is the current status of trial NCT01603264?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 105 participants. The study started on 2012-05. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01603264?
The interventions under investigation include: PF-05280014 (BIOLOGICAL), Herceptin (BIOLOGICAL).
Who is sponsoring clinical trial NCT01603264?
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 NCT01603264's enrollment target sits among peer trials
105 533rd of 2000 higher than 1,465 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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