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Completed

NCT Number: NCT01844804

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 levels among the different administration arms of PF-06438179 and the licensed infliximab products. Safety, tolerability, and immunologic response will also be evaluated throughout.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Overland Park, Kansas, 66212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-06438179

Biological

Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1

Other names: Infliximab-Pfizer

Remicade

Biological

Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1

Other names: Infliximab (European Union)

Primary outcomes

  1. Maximum Observed Serum Concentration (Cmax)

    Time frame: Day 1 - Day 57

  2. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUCt)

    Time frame: Day 1 - Day 57

  3. Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf)

    Time frame: Day 1 - Day 57

Secondary outcomes

  1. Systemic Clearance (CL)

    Time frame: Day 1 - Day 57

  2. Terminal Disposition Half-Life (t1/2)

    Time frame: Day 1 - Day 57

  3. Volume of Distribution at Steady State (Vss)

    Time frame: Day 1 - Day 57

  4. Incidence of anti-infliximab antibodies (ADA), including neutralizing antibodies (Nab)

    Time frame: Day 1 - LSLV or Day 85 whichever occurs later

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 1, 2013
Registry last updated
Jan 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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