A Pharmacokinetics Study Comparing PF-06438179 and Infliximab in Healthy Volunteers (REFLECTIONS B537-01)

January 6, 2014 updated by: Pfizer

Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study of PF-06438179 and Infliximab Sourced From US and EU Administered to Healthy Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy female subjects of non-childbearing potential and healthy male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
  • Body Mass Index (BMI) of 17.5 to 32.0 kg/m2; and a total body weight >50kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Previous exposure to a monoclonal antibody, or current use of other biologics.
  • History of hypersensitivity reaction to inactive components of the study drugs or any murine proteins or anaphylactic reactions to therapeutic drugs.
  • History of tuberculosis (TB) or a positive latent TB test at Screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A = PF-06438179
Biological: PF-06438179
Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1
Other Names:
  • Infliximab-Pfizer
Active Comparator: B = Infliximab-EU
Biological: Remicade
Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1
Other Names:
  • Infliximab (United States)
Active Comparator: C = Infliximab-US
Biological: Remicade
Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1
Other Names:
  • Infliximab (United States)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Observed Serum Concentration (Cmax)
Time Frame: Day 1 - Day 57
Day 1 - Day 57
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUCt)
Time Frame: Day 1 - Day 57
Day 1 - Day 57
Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf)
Time Frame: Day 1 - Day 57
Day 1 - Day 57

Secondary Outcome Measures

Outcome Measure
Time Frame
Systemic Clearance (CL)
Time Frame: Day 1 - Day 57
Day 1 - Day 57
Terminal Disposition Half-Life (t1/2)
Time Frame: Day 1 - Day 57
Day 1 - Day 57
Volume of Distribution at Steady State (Vss)
Time Frame: Day 1 - Day 57
Day 1 - Day 57
Incidence of anti-infliximab antibodies (ADA), including neutralizing antibodies (Nab)
Time Frame: Day 1 - LSLV or Day 85 whichever occurs later
Day 1 - LSLV or Day 85 whichever occurs later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (Estimate)

May 1, 2013

Study Record Updates

Last Update Posted (Estimate)

January 7, 2014

Last Update Submitted That Met QC Criteria

January 6, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B5371001
  • REFLECTIONS B537-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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