A Pharmacokinetic Study Comparing PF-06439535 And Bevacizumab In Healthy Male Volunteers (REFLECTIONS B739-01)
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 21 - 55 |
| Updated: | 5/5/2014 |
| Start Date: | January 2014 |
| End Date: | June 2014 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
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.
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.
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.
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