You are here

A SINGLE-DOSE, 2-ARM, PHARMACOKINETIC STUDY OF PF-06439535 (CN) AND EUROPEAN UNION SOURCED BEVACIZUMAB IN CHINESE HEALTHY MALE VOLUNTEERS

Last updated on November 18, 2019

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pharmacokinetics
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. 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.

2. 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) and alkaline phosphatase and adequate renal function (blood urea nitrogen (BUN)/urea normal and Creatinine

3. Body Mass Index (BMI) of 18 to 28 kg/m2; and a total body weight >50 kg (110 lbs).

4. Evidence of a personally signed and dated informed consent document indicating that
the subject has been informed of all pertinent aspects of the study.

5. Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. 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).

2. 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).

3. Evidence or history of relevant and clinically significant intra abdominal
inflammation, gastrointestinal perforation or gall bladder perforation.

4. 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.

5. Wounds that have not completely healed, active ulcer(s), or bone fracture(s).

6. Previous history of cancer, except for adequately treated basal cell or squamous cell
carcinoma of the skin.

7. 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.

8. Clinically significant abnormalities in laboratory test results.

9. 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.

10. 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.

11. A positive urine drug test.

12. History of febrile illness within 5 days prior to dosing.

13. Current use of tobacco or nicotine containing products in excess of the equivalent of
5 cigarettes per day.

14. History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces
[150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor)
within 6 months of Screening.

15. History of serious allergic or anaphylactic reaction to a therapeutic drug.

16. Treatment with an investigational drug within 30 days (or as determined by the local
requirement) or 5 half lives preceding the first dose of investigational product
(whichever is longer).

17. Use of prescription or nonprescription drugs and dietary supplements within 7 days or
5 half lives (whichever is longer) prior to the first dose of investigational product.
Use of anti platelet therapy eg, non steroidal anti inflammatory drugs (NSAIDs) is
excluded. Herbal supplements must be discontinued 28 days prior to the first dose of
investigational product. As an exception, acetaminophen/paracetamol may be used at
doses of to affect subject safety or the overall results of the study may be permitted on a
case by case basis, following approval by the sponsor.

18. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing.

19. History of sensitivity to heparin or heparin induced thrombocytopenia.

20. Unwilling or unable to comply with the criteria in the Lifestyle Requirements section
of this protocol.

21. History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive
testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody
(HepBcAb), or hepatitis C antibody (HCVAb).

22. Subjects who are investigator site staff members directly involved in the conduct of
the study and their family members, site staff members otherwise supervised by the
investigator, or subjects who are Pfizer employees, including their family members,
directly involved in the conduct of the study.

23. Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the subject inappropriate for entry into this
study.

NCT04126044
Pfizer
Not yet recruiting
A SINGLE-DOSE, 2-ARM, PHARMACOKINETIC STUDY OF PF-06439535 (CN) AND EUROPEAN UNION SOURCED BEVACIZUMAB IN CHINESE HEALTHY MALE VOLUNTEERS

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Descriptive Information
Brief Title  ICMJE A SINGLE-DOSE, 2-ARM, PHARMACOKINETIC STUDY OF PF-06439535 (CN) AND EUROPEAN UNION SOURCED BEVACIZUMAB IN CHINESE HEALTHY MALE VOLUNTEERS
Official Title  ICMJE 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
Brief SummaryThis 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Pharmacokinetics
Intervention  ICMJE
  • Drug: PF-06439535 (CN)
    This is the test drug Pfizer biosimilar of bevacizumab-EU.
  • Drug: bevacizumab - EU
    This is the reference drug bevacizumab sourced from EU
Study Arms  ICMJE
  • Active Comparator: Reference: bevacizumab - EU
    Intervention: Drug: bevacizumab - EU
  • Experimental: Test: PF-06439535 (CN)
    Intervention: Drug: PF-06439535 (CN)
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 11, 2019)
66
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 20, 2020
Estimated Primary Completion DateSeptember 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Body Mass Index (BMI) of 18 to 28 kg/m2; and a total body weight >50 kg (110 lbs).
  4. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
  5. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  1. 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).
  2. 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).
  3. Evidence or history of relevant and clinically significant intra abdominal inflammation, gastrointestinal perforation or gall bladder perforation.
  4. 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.
  5. Wounds that have not completely healed, active ulcer(s), or bone fracture(s).
  6. Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin.
  7. 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.
  8. Clinically significant abnormalities in laboratory test results.
  9. 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.
  10. 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.
  11. A positive urine drug test.
  12. History of febrile illness within 5 days prior to dosing.
  13. Current use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
  14. History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months of Screening.
  15. History of serious allergic or anaphylactic reaction to a therapeutic drug.
  16. Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).
  17. Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of investigational product. Use of anti platelet therapy eg, non steroidal anti inflammatory drugs (NSAIDs) is excluded. Herbal supplements must be discontinued 28 days prior to the first dose of investigational product. As an exception, acetaminophen/paracetamol may be used at doses of <=1 g/day. Limited use of non prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case by case basis, following approval by the sponsor.
  18. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
  19. History of sensitivity to heparin or heparin induced thrombocytopenia.
  20. Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of this protocol.
  21. History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb).
  22. Subjects who are investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
  23. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Gender Based Eligibility:Yes
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04126044
Other Study ID Numbers  ICMJE B7391005
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:No
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now