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A Pharmacokinetic Study Comparing PF-06439535 And Bevacizumab In Healthy Male Volunteers (REFLECTIONS B739-01)

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
South Miami, Florida, 33143 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
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male subjects 21-55 years old

- Subjects who have previously been exposed to a biologic agent (other than a VEGF
[Vascular Endothelial Growth Factor Receptor] inhibitor) may enroll provided that at
least 3 months have passed since the last administration of that drug

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50kg (110lbs)

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

- Evidence or history of a clinically significant disease or clinical finding at
Screening

- Previous treatment with an anti-VEGF antibody, or any other antibody or protein
targeting the VEGF receptor.

NCT02031991
Pfizer
Completed
A Pharmacokinetic Study Comparing PF-06439535 And Bevacizumab In Healthy Male Volunteers (REFLECTIONS B739-01)

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A Pharmacokinetic Study Comparing PF-06439535 And Bevacizumab In Healthy Male Volunteers (REFLECTIONS B739-01)
Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study Of PF-06439535 And Bevacizumab Sourced From US And EU Administered To Healthy Male Volunteers

This study is to prove that the handling (also referred to as pharmacokinetics) of the following drugs PF-06439535, Avastin® (bevacizumab) that is licensed for use in the United States (bevacizumab-US) and Avastin® (bevacizumab) obtained from Europe (bevacizumab-EU) is similar in healthy male volunteers after receiving a single intravenous dose of either drugs.

During the course of the study, the similarity in 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-06439535, bevacizumab-US and bevacizumab-EU. Safety, tolerability, and immunologic response to the administered drugs will also 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-06439535
    Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
    Other Name: PF-06439535, a potential biosimilar to bevacizumab
  • Biological: Avastin
    Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
    Other Name: Bevacizumab (European Union)
  • Biological: Avastin
    Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
    Other Name: Bevacizumab (United States)
  • Experimental: A = PF-06439535
    Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1.
    Intervention: Biological: PF-06439535
  • Active Comparator: B = Bevacizumab-EU
    Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1.
    Intervention: Biological: Avastin
  • Active Comparator: C = Bevacizumab-US
    Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1.
    Intervention: Biological: Avastin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
August 2014
August 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male subjects 21-55 years old
  • Subjects who have previously been exposed to a biologic agent (other than a VEGF [Vascular Endothelial Growth Factor Receptor] inhibitor) may enroll provided that at least 3 months have passed since the last administration of that drug
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50kg (110lbs)

Exclusion Criteria:

  • Evidence or history of a clinically significant disease or clinical finding at Screening
  • Previous treatment with an anti-VEGF antibody, or any other antibody or protein targeting the VEGF receptor.
Sexes Eligible for Study: Male
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02031991
B7391001
REFLECTIONS B739-01
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2014

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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