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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: PF-06439535; Biological: Avastin

• Registration Number: NCT02031991
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-07
• Study First Submitted QC: 2014-01-07
• Study First Posted: 2014-01-09
• Status Verified: 2014-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Last Update Submitted: 2014-08-14
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax)	Day 1 - Day 71
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)	Day 1 - Day 71
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	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).

Secondary Outcome Measures

Name	Time	Method
Terminal Disposition Half-Life (t1/2)	Day 1 - Day 71
Systemic Clearance (CL)	Day 1 - Day 71
Volume of Distribution at Steady State (Vss)	Day 1 - Day 71
Incidence of anti-bevacizumab antibodies (ADA), including neutralizing antibodies (Nab)	Day 1 - Day 71 or LSLV, whichever occurs later

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 South Miami, Florida, United States