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

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Biological: Avastin
Biological: PF-06439535

Study type

Interventional

Funder types

Industry

Identifiers

NCT02031991
REFLECTIONS B739-01
B7391001

Details and patient eligibility

About

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.

Enrollment

102 patients

Sex

Male

Ages

21 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

102 participants in 3 patient groups

A = PF-06439535
Experimental group
Description:
Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1.
Treatment:
Biological: PF-06439535
B = Bevacizumab-EU
Active Comparator group
Description:
Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1.
Treatment:
Biological: Avastin
Biological: Avastin
C = Bevacizumab-US
Active Comparator group
Description:
Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1.
Treatment:
Biological: Avastin
Biological: Avastin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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