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A Pharmacokinetic Study Comparing PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-01)

Last updated on May 10, 2018

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 30.5 kg/m2 and a total body weight > 50 kg (110 lbs).

- Male subjects must agree that they and their female spouse/partners will use adequate
contraception (2 forms of birth control, one of which must be barrier method) or be of
non-childbearing potential.

- Left ventricular ejection fraction (LVEF) within the normal range as measured by
echocardiogram (ECHO) within 8 weeks prior to randomization.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or
allergic disease, or clinical findings at screening excluding untreated, asymptomatic
seasonal allergies at time of dosing.

- Clinically significant abnormalities in laboratory test results.

- Previous exposure to a monoclonal antibody or current use of other biologics.

- History of allergic or anaphylactic reaction to a therapeutic drug or benzyl alcohol.

- Use of prescription or non prescription drugs and dietary supplements within 7 days or
5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal
supplements must be discontinued 28 days prior to the first dose of study medication.

- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.

NCT01603264
Pfizer
Completed
A Pharmacokinetic Study Comparing PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-01)

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A Pharmacokinetic Study Comparing PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-01)
Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study Of PF-05280014 And Trastuzumab Sourced From US And EU Administered To Healthy Male Volunteers
In this study, healthy male volunteers will receive a single intravenous administration of either PF-05280014 or trastuzumab (United States) or trastuzumab (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-05280014 and the US-licensed and EU-approved trastuzumab products. Safety, tolerability, and immunologic response also will be evaluated throughout.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Healthy
  • 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 Name: Trastuzumab-Pfizer
  • Biological: Herceptin
    Concentrate for solution for infusion, sterile vial 150 mg, single-dose 6 mg/kg administered as 90-minute infusion on day 1
    Other Name: Trastuzumabum (European Union)
  • 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 Name: Trastuzumab (United States)
  • Experimental: A
    PF-05280014
    Intervention: Biological: PF-05280014
  • Active Comparator: B
    Trastuzumab-EU
    Intervention: Biological: Herceptin
  • Active Comparator: C
    Trastuzumab-US
    Intervention: Biological: Herceptin
Yin D, Barker KB, Li R, Meng X, Reich SD, Ricart AD, Rudin D, Taylor CT, Zacharchuk CM, Hansson AG. A randomized phase 1 pharmacokinetic trial comparing the potential biosimilar PF-05280014 with trastuzumab in healthy volunteers (REFLECTIONS B327-01). Br J Clin Pharmacol. 2014 Dec;78(6):1281-90. doi: 10.1111/bcp.12464.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 30.5 kg/m2 and a total body weight > 50 kg (110 lbs).
  • Male subjects must agree that they and their female spouse/partners will use adequate contraception (2 forms of birth control, one of which must be barrier method) or be of non-childbearing potential.
  • Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiogram (ECHO) within 8 weeks prior to randomization.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease, or clinical findings at screening excluding untreated, asymptomatic seasonal allergies at time of dosing.
  • Clinically significant abnormalities in laboratory test results.
  • Previous exposure to a monoclonal antibody or current use of other biologics.
  • History of allergic or anaphylactic reaction to a therapeutic drug or benzyl alcohol.
  • Use of prescription or non prescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements must be discontinued 28 days prior to the first dose of study medication.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01603264
B3271001
REFLECTIONS B327-01
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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