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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02458209
First received: May 1, 2015
Last updated: March 7, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Healthy Biological: bococizumab PFS:Pfizer Biological: bococizumab PFS: BIP Biological: bococizumab PFP Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Cmax [ Time Frame: Day 1 - Day 85 ]
    maximal plasma concentration

  • AUCinf [ Time Frame: Day 1 - Day 85 ]
    area under the concentration time curve from time 0 extrapolated to infinite time (AUCinf)

  • Cmax for bococizumab using DS from Pfizer as comapred to DS from BIP [ Time Frame: Day 1 - Day 85 ]
    Cmax of bococizumab using drug substance (DS) manufactured by Pfizer vs. DS manufactured by BIP

  • AUCinf for bococizumab using DS from Pfizer as comapred to DS from BIP [ Time Frame: Day 1 - Day 85 ]
    Cmax of bococizumab using drug substance (DS) manufactured by Pfizer vs. DS manufactured by BIP

  • Cmax for bococizumab using PFS as comapred to PFP [ Time Frame: Day 1 - Day 85 ]
    Cmax of bococizumab administered via prefilled syringe vs. a prefilled pen

  • AUCinf for bococizumab using PFS as comapred to PFP [ Time Frame: Day 1 - Day 85 ]
    AUcinf of bococizumab administered via prefilled syringe vs. a prefilled pen


Secondary Outcome Measures:
  • MaxELDL-C [ Time Frame: Day 1 - Day 85 ]
    Maximum lowering in LDL C

  • AUEClast [ Time Frame: Day 1 - Day 85 ]
    Area under the LDL C concentration time profile from time zero to the time of the last quantifiable concentration (Clast)

  • Tmax,LDL-C [ Time Frame: Day 1 - Day 85 ]
    Time for MaxELDL- C

  • Tmax [ Time Frame: Day 1 - Day 85 ]
    Time to Cmax

  • CL/F [ Time Frame: Day 1 - Day 85 ]
    apparent clearance

  • Vz/F [ Time Frame: Day 1 - Day 85 ]
    Apparent volume of distribution

  • T1/2 [ Time Frame: Day 1 - Day 85 ]
    terminal half-life

  • AUClast [ Time Frame: Day 1 - Day 85 ]
    Area under the concentration time curve from time 0 to the time of last quantifiable concentration

  • Incidence of ADAs and neutralizing antibodies [ Time Frame: Day 1 - 85 ]
    Incidence of anti-drug antibodies and neutralizing antibodies (if applicable).

  • Titer for ADAs and neutralizing antibodies [ Time Frame: Day 1 - 85 ]
    Titer for anti-drug antibodies and neutralizing antibodies (if applicable).

  • Incidence, severity and causal relationship of treatment emergent AEs [ Time Frame: Day 1 - 85 ]
    Incidence, severity and causal relationship of treatment emergent AEs (TEAEs)

  • Incidence and severity of ISRs [ Time Frame: Day 1 - 85 ]
    Incidence, and severity of injection site reactions

  • Incidence of abnormal and clinically relevant safety laboratory parameters [ Time Frame: Day 1 - 85 ]
    Incidence of abnormal and clinically relevant safety laboratory tests including clinical chemistry, hematology, and vital signs.

  • MaxELDL-C using DS from Pfizer as compared to BIP, if applicable [ Time Frame: Day 1 - Day 85 ]
    Maximum lowering in LDL-C using DS manufactured by Pfizer vs. BIP, if applicable

  • AUEClast using DS from Pfizer as compared to BIP, if applicable [ Time Frame: Day 1 - Day 85 ]
    Area under the LDL-C curve using DS manufactured by Pfizer vs. BIP, if applicable

  • MaxELDL-C using PFS as compared to PFP, if applicable [ Time Frame: Day 1 - Day 85 ]
    Maximum lowering in LDL-C using prefilled syringe vs. prefilled pen , if applicable

  • AUEClast using PFS as compared to PFP, if applicable [ Time Frame: Day 1 - Day 85 ]
    Area under the LDL-C curve using prefilled syringe vs. prefilled pen , if applicable


Other Outcome Measures:
  • PCSK9 [ Time Frame: Day 1 - Day 85 ]
    on trial ng/mL PCSK9 concentration, ng/mL change from baseline and percent change from baseline in PCSK9 following bococizumab administration

  • total cholesterole [ Time Frame: Day 1 - Day 85 ]
    on trial mg/mL total cholesterol concentration, change from baseline and percent change from baseline in total cholesterol following bococizumab administration

  • HDL-C [ Time Frame: Day 1 - Day 85 ]
    on trial mg/mL HDL-C concentration, change from baseline and percent change from baseline in HDL-C following bococizumab administration

  • Non HDL-C [ Time Frame: Day 1 - Day 85 ]
    on trial mg/mL non HDL-C concentration, change from baseline and percent change from baseline in non HDL-C following bococizumab administration

  • triglyceride [ Time Frame: Day 1 - Day 85 ]
    on trial mg/mL triglyceride concentration, change from baseline and percent change from baseline in triglyceride following bococizumab administration


Enrollment: 470
Study Start Date: May 2015
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment A
150 mg SC dose administered in a prefilled syringe using drug substance manufactured at Pfizer Andover
Biological: bococizumab PFS:Pfizer
150 mg bococizumab administered SC in a prefilled syringe using drug substance manufactured at Pfizer Andover
Experimental: Treatment B
• Treatment B: 150 mg SC dose administered in a prefilled syringe using drug substance manufactured at Boehringer Ingelheim Pharma
Biological: bococizumab PFS: BIP
150 mg bococizumab administered SC in a prefilled syringe using drug substance manufactured at Boehringer Ingelheim Pharma.
Experimental: Treatment C
150 mg SC dose administered in a prefilled pen using drug substance manufactured at Pfizer Andover.
Biological: bococizumab PFP
150 mg bococizumab administered SC in a prefilled pen using drug substance manufactured at Pfizer Andover

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02458209

Locations
United States, Florida
Broward Research Group
Hollywood, Florida, United States, 33024
Miami Research Associates, LLC
South Miami, Florida, United States, 33143
MRA Clinical Research, LLC
South Miami, Florida, United States, 33143
United States, Minnesota
Prism Research, LLC
Saint Paul, Minnesota, United States, 55114
United States, North Carolina
High Point Clinical Trials Center, LLC
High Point, North Carolina, United States, 27265
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02458209     History of Changes
Other Study ID Numbers: B1481026
Study First Received: May 1, 2015
Last Updated: March 7, 2016

Keywords provided by Pfizer:
PK, bococizumab, comparability, LDL-C

ClinicalTrials.gov processed this record on September 19, 2017