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Single Dose Manufacturing Site (Pfizer vs. BIP) And Device (Prefilled Syringe vs. Prefilled Pen) Comparability Study For Bococizumab In Healthy Volunteers

Last updated on December 12, 2019

FOR MORE INFORMATION
Study Location
Broward Research Group
Hollywood, Florida, 33024 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Healthy male and/or female subjects between the ages of 18 and 65 years

2. Body Mass Index (BMI) 33.0 kg/m2 or lower; and a total body weight 60 to 90 kg (132
198 lbs) inclusive

3. Fasting LDL-C must be 80 to 200 mg/dL at two qualifying visits: initial screening
(Days -28 to -14) and Day -7.

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 disease or other severe acute or
chronic medical or psychiatric condition 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

2. Any condition possibly affecting drug absorption.

3. Pregnant/breast feeding female subjects; male subjects with partners currently
pregnant; male & female subjects of childbearing potential who are unwilling or
unable to use a highly effective method of contraception

4. History of allergic or anaphylactic reaction to any therapeutic or diagnostic mAb or
molecules made of components of mAb

5. History of regular alcohol consumption : >7 drinks/wk (F) or 14 drinks/wk (M)

6. History of sensitivity to heparin or heparin?induced thrombocytopenia.

7. Positive urine drug screen.

8. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 56 days prior to dosing.

9. Screening seated BP of 140/90 mm Hg or higher

10. Screening 12?lead ECG demonstrating QTc >450 or a QRS interval >120 msec

11. Subjects with prior exposure to bococizumab (also known as PF?04950615 or RN316) or
other investigational PCSK9 inhibitors.

12. Treatment with marketed or investigational mAbs within 6 months or 5 half?lives of
Day 1

13. Treatment with an investigational drug within 30 days or 5 half?lives of Day 1,
and/or anticipated to take part in a clinical study during the duration of this
study.

14. Use of prescription or nonprescription drugs within 7 days or 5 half?lives of Day 1;

15. Abnormal labs:

AST/SGOT or ALT/SGPT greater than or equal to 1.2 × ULN; total bilirubin greater than
or equal to 1.5 × ULN; CK >1.5 × ULN or absolute value >600 U/L.

16. Unwilling or unable to comply with the Lifestyle Guidelines described in this
protocol.

17. Subjects who are investigational 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 directly involved in the conduct
of the study.

NCT02458209
Pfizer
Completed
Single Dose Manufacturing Site (Pfizer vs. BIP) And Device (Prefilled Syringe vs. Prefilled Pen) Comparability Study For Bococizumab In Healthy Volunteers

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Descriptive Information
Brief Title  ICMJE Single Dose Manufacturing Site (Pfizer vs. BIP) And Device (Prefilled Syringe vs. Prefilled Pen) Comparability Study For Bococizumab In Healthy Volunteers
Official Title  ICMJE A Phase 1, Open-label, Randomized, Single Dose, Parallel Group Comparability Study To Assess The Subcutaneous Pharmacokinetics And Pharmacodynamics Of Bococizumab In Healthy Adult Subjects For Comparisons Of Drug Substance Manufactured At Two Different Locations And Administration Via Prefilled Syringe Vs. Prefilled Pen
Brief Summary This is an open label, single dose, randomized, parallel group study in healthy adult subjects to assess the comparability of bococizumab administered in a prefilled syringe vs. prefilled pen and comparability between drug substance manufactured at Pfizer Andover vs. Boehringer Ingelheim Pharma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: bococizumab PFS:Pfizer
    150 mg bococizumab administered SC in a prefilled syringe using drug substance manufactured at Pfizer Andover
  • Biological: bococizumab PFS: BIP
    150 mg bococizumab administered SC in a prefilled syringe using drug substance manufactured at Boehringer Ingelheim Pharma.
  • Biological: bococizumab PFP
    150 mg bococizumab administered SC in a prefilled pen using drug substance manufactured at Pfizer Andover
Study Arms  ICMJE
  • Active Comparator: Treatment A
    150 mg SC dose administered in a prefilled syringe using drug substance manufactured at Pfizer Andover
    Intervention: Biological: bococizumab PFS:Pfizer
  • Experimental: Treatment B
    ? Treatment B: 150 mg SC dose administered in a prefilled syringe using drug substance manufactured at Boehringer Ingelheim Pharma
    Intervention: Biological: bococizumab PFS: BIP
  • Experimental: Treatment C
    150 mg SC dose administered in a prefilled pen using drug substance manufactured at Pfizer Andover.
    Intervention: Biological: bococizumab PFP
Publications * Wang EQ, Plotka A, Salageanu J, Baltrukonis D, Mridha K, Frederich R, Sullivan BE. Comparative Pharmacokinetics and Pharmacodynamics of Bococizumab Following a Single Subcutaneous Injection Using Drug Substance Manufactured at Two Sites or Administration via Two Different Devices. Clin Pharmacol Drug Dev. 2019 Jan;8(1):40-48. doi: 10.1002/cpdd.454. Epub 2018 Apr 24.


*   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 Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2016)
470
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2015)
465
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy male and/or female subjects between the ages of 18 and 65 years
  2. Body Mass Index (BMI) 33.0 kg/m2 or lower; and a total body weight 60 to 90 kg (132 198 lbs) inclusive
  3. Fasting LDL-C must be 80 to 200 mg/dL at two qualifying visits: initial screening (Days -28 to -14) and Day -7.
  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 disease or other severe acute or chronic medical or psychiatric condition 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
  2. Any condition possibly affecting drug absorption.
  3. Pregnant/breast feeding female subjects; male subjects with partners currently pregnant; male & female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception
  4. History of allergic or anaphylactic reaction to any therapeutic or diagnostic mAb or molecules made of components of mAb
  5. History of regular alcohol consumption : >7 drinks/wk (F) or 14 drinks/wk (M)
  6. History of sensitivity to heparin or heparin?induced thrombocytopenia.
  7. Positive urine drug screen.
  8. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
  9. Screening seated BP of 140/90 mm Hg or higher
  10. Screening 12?lead ECG demonstrating QTc >450 or a QRS interval >120 msec
  11. Subjects with prior exposure to bococizumab (also known as PF?04950615 or RN316) or other investigational PCSK9 inhibitors.
  12. Treatment with marketed or investigational mAbs within 6 months or 5 half?lives of Day 1
  13. Treatment with an investigational drug within 30 days or 5 half?lives of Day 1, and/or anticipated to take part in a clinical study during the duration of this study.
  14. Use of prescription or nonprescription drugs within 7 days or 5 half?lives of Day 1;
  15. Abnormal labs:

    AST/SGOT or ALT/SGPT greater than or equal to 1.2 × ULN; total bilirubin greater than or equal to 1.5 × ULN; CK >1.5 × ULN or absolute value >600 U/L.

  16. Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
  17. Subjects who are investigational 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 directly involved in the conduct of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02458209
Other Study ID Numbers  ICMJE B1481026
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2016

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