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NCT01844804 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetics Study Comparing PF-06438179 and Infliximab in Healthy Volunteers (REFLECTIONS B537-01)
A Phase 1 study of Healthy, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 146
- Enrollment target
- 1
- Study location
NCT01844804: Completed Phase 1 study of Healthy, sponsored by Pfizer.
NCT01844804 is a Phase 1 study of Healthy that has completed, run by Pfizer. The registered enrollment target is 146 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01844804, a Phase 1 study of Healthy, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 146 participants
- Enrollment target
- 1
- Study location
Study Summary
In this study, healthy volunteers will receive a single intravenous dose of either PF-06438179 or infliximab (United States) or infliximab (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-06438179 and the licensed infliximab products. Safety, tolerability, and immunologic response will also be evaluated throughout.
Conditions Studied
Interventions
- BIOLOGICAL Remicade
- BIOLOGICAL PF-06438179
Study Locations (1)
Kansas
- Pfizer Investigational Site - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2013-05 |
| Est. Completion | 2013-11 |
| Phase | Phase 1 |
What the finished NCT01844804 record still lists
NCT01844804 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Remicade is the first listed.
NCT01844804 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT01844804 about?
NCT01844804 is a clinical study titled "A Pharmacokinetics Study Comparing PF-06438179 and Infliximab in Healthy Volunteers (REFLECTIONS B537-01)". In this study, healthy volunteers will receive a single intravenous dose of either PF-06438179 or infliximab (United States) or infliximab (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 level...
What is the current status of trial NCT01844804?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 146 participants. The study started on 2013-05. Estimated completion is 2013-11.
What conditions does trial NCT01844804 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01844804?
The interventions under investigation include: Remicade (BIOLOGICAL), PF-06438179 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01844804?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01844804 being conducted?
This trial has 1 study location across Kansas. 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 NCT01844804's enrollment target sits among peer trials
146 158th of 1090 higher than 933 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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