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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 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.

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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

FieldValue
Enrollment Target 146 participants
Start Date 2013-05
Est. Completion 2013-11
Phase Phase 1

Sponsor

Pfizer

1,845 total trials

What the Registry Record Tells You About NCT01844804

The ClinicalTrials.gov registry entry for NCT01844804 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 146 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (77% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.