A DOUBLE BLIND, RANDOMIZED, PARALLEL-GROUP, SINGLE-DOSE, 2-ARM, COMPARATIVE PHARMACOKINETIC STUDY OF PF-06439535 (CN) AND BEVACIZUMAB SOURCED FROM EUROPEAN UNION ADMINISTERED TO CHINESE HEALTHY MALE VOLUNTEERS

Pfizer1 site in 1 countryJanuary 22, 2021

ConditionsPharmacokinetics

Interventionsbevacizumab - EU PF-06439535 (CN)

DrugsPF-06439535 (CN)bevacizumab - EU

Overview

Phase: Phase 1
Intervention: bevacizumab - EU
Conditions: Pharmacokinetics
Sponsor: Pfizer
Locations: 1
Primary Endpoint: AUC0-t (Area under the serum concentration-time profile from time 0 to last time point with quantifiable concentration)
Status: Withdrawn
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a double-blind, randomized (1:1), parallel group, single dose, 2-arm, comparative PK study of PF-06439535 (CN) and bevacizumab-EU administered intravenously to Chinese healthy male volunteers. Approximately 66 subjects will be enrolled to ensure that at least 58 subjects (29 per arm) complete the study procedures and have evaluable PK data. The study will be conducted at 1 center in China.

Registry

clinicaltrials.gov

Start Date

January 22, 2021

End Date

July 10, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy Chinese male subjects who, at the time of screening, are between the ages of 21 55 years of age, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate (PR) measurement, 12 lead electrocardiogram (ECG), or clinical laboratory tests.
•Subjects must have adequate organ function (excluding subjects who received blood transfusions) according to the following laboratory values: bone marrow function (absolute neutrophil count (ANC) \>=1,500/mm3 and platelet count of 100,000/mm3), adequate liver function (alanine aminotransferase (ALT) \<=3 times upper limit normal and alkaline phosphatase \<= 2 times upper limit normal, total bilirubin \<= 1.5 mg/dl), and adequate renal function (blood urea nitrogen (BUN)/urea \<=1.5 times institutional normal and Creatinine \<1.5 mg/dl) upon study entry.
•Body Mass Index (BMI) of 18 to 28 kg/m2; and a total body weight \>50 kg (110 lbs).
•Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
•Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria

•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
•Evidence or history of heart failure, arterial or venous thromboembolism, bleeding diathesis, acquired coagulopathy or coagulopathy factor abnormality with international normalized ratio (INR) of \>=1.5, or history of gross hemorrhage within the past 6 months prior to Screening (eg, hemoptysis or hematuria requiring medical intervention).
•Evidence or history of relevant and clinically significant intra abdominal inflammation, gastrointestinal perforation or gall bladder perforation.
•Major surgery or elective surgery within 3 months before or after administration of study treatment. At least 28 days should elapse from the time of minor surgical procedure, including placement of an access device and dental procedures.
•Wounds that have not completely healed, active ulcer(s), or bone fracture(s).
•Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin.
•Screening supine BP \>= 140 mm Hg (systolic) or \>= 90 mm Hg (diastolic) on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest. If BP is \>= 140 mm Hg (systolic) or \>= 90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the subject's eligibility.
•Clinically significant abnormalities in laboratory test results.
•Screening supine 12 lead ECG demonstrating a corrected QT (QTc) interval \>450 msec or a QRS interval \>120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the subject's eligibility.
•Fertile male subjects who are unwilling or unable to use highly effective methods of contraception as outlined in this protocol (refer to Section 4.4.4) for 71 days following study drug administration.

Arms & Interventions

Reference: bevacizumab - EU

Intervention: bevacizumab - EU

Test: PF-06439535 (CN)

Intervention: PF-06439535 (CN)

Outcomes

Primary Outcomes

AUC0-t (Area under the serum concentration-time profile from time 0 to last time point with quantifiable concentration)

Time Frame: From Day 1 to Day 71

Secondary Outcomes

Cmax (Maximum observed concentration derived from serum)(From Day 1 to Day 71)
AUCinf (Area under the serum concentration-time profile from time zero extrapolated to infinity)(From Day 1 to Day 71)
clerance (CL)(From Day 1 to Day 71)
terminal half-life (t1/2)(From Day 1 to Day 71)
steady state volume of distribution (Vss)(From Day 1 to Day 71)
Percentage of participants with treatment emergent adverse events(From screening until Day 71 (total period of approximately 99 days))
Percentage of participants with clinical laboratory test results above/below certain threshold(At screening; Days -1, 2, 8, 29, 71)
Incidence of anti-drug antibodies (ADA)(From day 1 to day 71)
Incidence of neutralizing antibodies (Nab)(From Day 1 to Day 71)