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

NCT02458209 | Completed Phase 1

• 1 other identifier: B1481026
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 5

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.

Conditions

Healthy

Keywords

PK, bococizumab, comparability, LDL-C

Outcome Measures

Primary Outcomes (6)

• Cmax

  maximal plasma concentration

  Day 1 - Day 85

• AUCinf

  area under the concentration time curve from time 0 extrapolated to infinite time (AUCinf)

  Day 1 - Day 85

• Cmax for bococizumab using DS from Pfizer as comapred to DS from BIP

  Cmax of bococizumab using drug substance (DS) manufactured by Pfizer vs. DS manufactured by BIP

  Day 1 - Day 85

• AUCinf for bococizumab using DS from Pfizer as comapred to DS from BIP

  Cmax of bococizumab using drug substance (DS) manufactured by Pfizer vs. DS manufactured by BIP

  Day 1 - Day 85

• Cmax for bococizumab using PFS as comapred to PFP

  Cmax of bococizumab administered via prefilled syringe vs. a prefilled pen

  Day 1 - Day 85

• AUCinf for bococizumab using PFS as comapred to PFP

  AUcinf of bococizumab administered via prefilled syringe vs. a prefilled pen

  Day 1 - Day 85

Secondary Outcomes (17)

• MaxELDL-C

  Day 1 - Day 85

• AUEClast

  Day 1 - Day 85

• Tmax,LDL-C

  Day 1 - Day 85

• Tmax

  Day 1 - Day 85

• CL/F

  Day 1 - Day 85

Other Outcomes (5)

• PCSK9

  Day 1 - Day 85

• total cholesterole

  Day 1 - Day 85

• HDL-C

  Day 1 - Day 85

Study Arms (3)

Treatment A

ACTIVE COMPARATOR

150 mg SC dose administered in a prefilled syringe using drug substance manufactured at Pfizer Andover

Biological: bococizumab PFS:Pfizer

Treatment B

EXPERIMENTAL

• Treatment B: 150 mg SC dose administered in a prefilled syringe using drug substance manufactured at Boehringer Ingelheim Pharma

Biological: bococizumab PFS: BIP

Treatment C

EXPERIMENTAL

150 mg SC dose administered in a prefilled pen using drug substance manufactured at Pfizer Andover.

Biological: bococizumab PFP

Interventions

bococizumab PFS:Pfizer BIOLOGICAL

150 mg bococizumab administered SC in a prefilled syringe using drug substance manufactured at Pfizer Andover

Treatment A

bococizumab PFS: BIP BIOLOGICAL

150 mg bococizumab administered SC in a prefilled syringe using drug substance manufactured at Boehringer Ingelheim Pharma.

Treatment B

bococizumab PFP BIOLOGICAL

150 mg bococizumab administered SC in a prefilled pen using drug substance manufactured at Pfizer Andover

Treatment C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and/or female subjects between the ages of 18 and 65 years
• Body Mass Index (BMI) 33.0 kg/m2 or lower; and a total body weight 60 to 90 kg (132 198 lbs) inclusive
• Fasting LDL-C must be 80 to 200 mg/dL at two qualifying visits: initial screening (Days -28 to -14) and Day -7.
• 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.

You may not qualify if:

• 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
• Any condition possibly affecting drug absorption.
• 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
• History of allergic or anaphylactic reaction to any therapeutic or diagnostic mAb or molecules made of components of mAb
• History of regular alcohol consumption : \>7 drinks/wk (F) or 14 drinks/wk (M)
• History of sensitivity to heparin or heparin-induced thrombocytopenia.
• Positive urine drug screen.
• Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
• Screening seated BP of 140/90 mm Hg or higher
• Screening 12-lead ECG demonstrating QTc \>450 or a QRS interval \>120 msec
• Subjects with prior exposure to bococizumab (also known as PF-04950615 or RN316) or other investigational PCSK9 inhibitors.
• Treatment with marketed or investigational mAbs within 6 months or 5 half-lives of Day 1
• 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.
• Use of prescription or nonprescription drugs within 7 days or 5 half-lives of Day 1;
• Abnormal labs:

Sponsors & Collaborators

• Pfizer: lead

Study Sites (5)

Broward Research Group

Hollywood, Florida, 33024, United States

Location

Miami Research Associates, LLC

South Miami, Florida, 33143, United States

Location

MRA Clinical Research, LLC

South Miami, Florida, 33143, United States

Location

Prism Research, LLC

Saint Paul, Minnesota, 55114, United States

Location

High Point Clinical Trials Center, LLC

High Point, North Carolina, 27265, United States

Location

Related Publications (2)

• Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.

  PMID: 37994400 DERIVED

• 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.

  PMID: 29688615 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2015
• First Posted: June 1, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 8, 2016

Record last verified: 2016-03

Locations

US (5)