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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 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 105 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01603264
The ClinicalTrials.gov registry entry for NCT01603264 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 105 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 2 interventions - of which PF-05280014 is the first listed.
NCT01603264 reports 0 study locations.
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.
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