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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02031991

Run by

Pfizer

People needed

102

Starts

2014-01-01

Expected to finish

2014-08-01

Last updated by the study team

2014-08-15

Who can join

Age: 21 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — South Miami, Florida, United States

Full record on ClinicalTrials.gov

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