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

Phase 1CompletedNCT02031991

Pfizer102 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

102

Conditions

Healthy

Interventions

Eligibility

Sex: MALEMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Maximum Observed Plasma Concentration (Cmax)

Time frame: Day 1 - Day 71

Area Under the Curve from Time Zero to end of dosing interval (AUCtau)

Time frame: Day 1 - Day 71

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

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).

Time frame: Day 1 - Day 71

Secondary Outcomes

Systemic Clearance (CL)

Time frame: Day 1 - Day 71

Terminal Disposition Half-Life (t1/2)

Time frame: Day 1 - Day 71

Volume of Distribution at Steady State (Vss)

Time frame: 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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes