A Study Evaluating The Safety Of PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-06)

April 21, 2014 updated by: Pfizer

Phase 1, Double-Blind, Randomized, Parallel-Group, Single-Dose, 2-Arm, Safety Study Of PF-05280014 And Trastuzumab Sourced From The US Administered To Healthy Male Volunteers

This study is to prove that there is no difference in the number of healthy male volunteers that will experience pyrexia (i.e. fever with body temperature of 38°C or higher) within a 24 hour period after administration of a single dose of 6mg/kg of PF-05280014 or trastuzumab sourced from the United States (trastuzumab-US). The study will also compare the safety of both drugs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Safety evaluation.

Study Type

Interventional

Enrollment (Actual)

162

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, 66211
        • Pfizer Investigational Site
      • 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

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Body Mass Index (BMI) of 17.5 to 30.5 kg^m2; and a total body weight >50 kg (110 lbs).
  • Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiogram (ECHO) within 8 weeks prior to randomization.
  • Subjects who have previously been exposed to a biologic agent (other than a HER2 inhibitor) may enroll provided that at least 3 months have passed since the last administration of that drug.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Previous exposure to an anti-HER2 antibody.
  • History of serious allergic or anaphylactic reaction to a therapeutic drug or benzyl alcohol.

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PF-05280014
Biological: PF-05280014
Concentrate for solution for infusion, sterile vial 150 mg, single-dose 6 mg/kg administered as 90-minute infusion on Day 1
Other Names:
  • Trastuzumab-Pfizer
Active Comparator: Trastuzumab-US
Biological: Herceptin®
Concentrate for solution for infusion, sterile vial 440 mg, single-dose 6 mg/kg administered as 90-minute infusion on Day 1
Other Names:
  • Trastuzumab-US

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of body temperature greater than or equal to 38.0 degrees Celsius
Time Frame: within 24 hours
within 24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of pyrexia
Time Frame: within 24 hours
within 24 hours
Severity of pyrexia
Time Frame: within 24 hours
within 24 hours
Timing of pyrexia
Time Frame: within 24 hours
within 24 hours
Seriousness of pyrexia
Time Frame: within 24 hours
within 24 hours
Relationship of study therapy to pyrexia
Time Frame: within 24 hours
within 24 hours
Incidence of body temperature greater than or equal to 38.0°C and/or use of concomitant treatment associated with fever suppression
Time Frame: within 24 hours
within 24 hours

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.

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

January 1, 2014

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

December 6, 2013

First Submitted That Met QC Criteria

December 12, 2013

First Posted (Estimate)

December 19, 2013

Study Record Updates

Last Update Posted (Estimate)

April 23, 2014

Last Update Submitted That Met QC Criteria

April 21, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B3271006
  • REFLECTIONS B327-06

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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