Single Dose Manufacturing Site (Pfizer vs. BIP) And Device (Prefilled Syringe vs. Prefilled Pen) Comparability Study For Bococizumab In Healthy Volunteers
NCT02458209
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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.
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.
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Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | 470 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |