A Pharmacokinetic Study Comparing PF-06439535 And Bevacizumab In Healthy Male Volunteers (REFLECTIONS B739-01)
August 14, 2014 updated by: Pfizer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
102
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
-
-
Florida
-
South Miami, Florida, United States, 33143
- 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
21 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
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
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A = PF-06439535
Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1.
|
Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
Other Names:
|
|
Active Comparator: B = Bevacizumab-EU
Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1.
|
Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
Other Names:
|
|
Active Comparator: C = Bevacizumab-US
Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1.
|
Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Day 1 - Day 71
|
Day 1 - Day 71
|
|
|
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Time Frame: Day 1 - Day 71
|
Day 1 - Day 71
|
|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Time Frame: Day 1 - Day 71
|
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8).
It is obtained from AUC (0 - t) plus AUC (t - 8).
|
Day 1 - Day 71
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Systemic Clearance (CL)
Time Frame: Day 1 - Day 71
|
Day 1 - Day 71
|
|
Terminal Disposition Half-Life (t1/2)
Time Frame: Day 1 - Day 71
|
Day 1 - Day 71
|
|
Volume of Distribution at Steady State (Vss)
Time Frame: Day 1 - Day 71
|
Day 1 - Day 71
|
|
Incidence of anti-bevacizumab antibodies (ADA), including neutralizing antibodies (Nab)
Time Frame: Day 1 - Day 71 or LSLV, whichever occurs later
|
Day 1 - Day 71 or LSLV, whichever occurs later
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
January 7, 2014
First Submitted That Met QC Criteria
January 7, 2014
First Posted (Estimate)
January 9, 2014
Study Record Updates
Last Update Posted (Estimate)
August 15, 2014
Last Update Submitted That Met QC Criteria
August 14, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B7391001
- REFLECTIONS B739-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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