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HealthyPhase 1NCT02458209

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

A Phase 1 study testing bococizumab PFS:Pfizer, bococizumab PFS: BIP and bococizumab PFP in people with Healthy, run by Pfizer at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
bococizumab PFS:Pfizer, bococizumab PFS: BIP and bococizumab PFP
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
470 participants
Where
5 sitesUnited States
Study dates
May 2015to Dec 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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:
  • 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.
  • Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • High Point Clinical Trials Center, LLC

    High Point, North Carolina, 27265

  • Broward Research Group

    Hollywood, Florida, 33024

  • Prism Research, LLC

    Saint Paul, Minnesota, 55114

  • Miami Research Associates, LLC

    South Miami, Florida, 33143

  • MRA Clinical Research, LLC

    South Miami, Florida, 33143

Other trials in United States

About this study

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

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
Being tested
bococizumab PFS:Pfizer, bococizumab PFS: BIP, bococizumab PFP
Keywords
PK, bococizumab, comparability, LDL-C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bococizumab PFS:PfizerBiological

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

  • bococizumab PFS: BIPBiological

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

  • bococizumab PFPBiological

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

Study groups in NCT02458209
Study groupRoleWhat they receive
Treatment AActive comparator150 mg SC dose administered in a prefilled syringe using drug substance manufactured at Pfizer Andover
Receives: Biological: bococizumab PFS:Pfizer
Treatment BExperimental• Treatment B: 150 mg SC dose administered in a prefilled syringe using drug substance manufactured at Boehringer Ingelheim Pharma
Receives: Biological: bococizumab PFS: BIP
Treatment CExperimental150 mg SC dose administered in a prefilled pen using drug substance manufactured at Pfizer Andover.
Receives: Biological: bococizumab PFP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax

    maximal plasma concentration

    Measured: Day 1 - Day 85

  2. AUCinf

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

    Measured: Day 1 - Day 85

  3. 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

    Measured: Day 1 - Day 85

  4. 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

    Measured: Day 1 - Day 85

  5. Cmax for bococizumab using PFS as comapred to PFP

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

    Measured: Day 1 - Day 85

  6. AUCinf for bococizumab using PFS as comapred to PFP

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

    Measured: Day 1 - Day 85

Secondary outcomes (17)

  1. MaxELDL-C

    Maximum lowering in LDL C

    Measured: Day 1 - Day 85

  2. AUEClast

    Area under the LDL C concentration time profile from time zero to the time of the last quantifiable concentration (Clast)

    Measured: Day 1 - Day 85

  3. Tmax,LDL-C

    Time for MaxELDL- C

    Measured: Day 1 - Day 85

  4. Tmax

    Time to Cmax

    Measured: Day 1 - Day 85

  5. CL/F

    apparent clearance

    Measured: Day 1 - Day 85

  6. Vz/F

    Apparent volume of distribution

    Measured: Day 1 - Day 85

  7. T1/2

    terminal half-life

    Measured: Day 1 - Day 85

  8. AUClast

    Area under the concentration time curve from time 0 to the time of last quantifiable concentration

    Measured: Day 1 - Day 85

  9. Incidence of ADAs and neutralizing antibodies

    Incidence of anti-drug antibodies and neutralizing antibodies (if applicable).

    Measured: Day 1 - 85

  10. Titer for ADAs and neutralizing antibodies

    Titer for anti-drug antibodies and neutralizing antibodies (if applicable).

    Measured: Day 1 - 85

  11. Incidence, severity and causal relationship of treatment emergent AEs

    Incidence, severity and causal relationship of treatment emergent AEs (TEAEs)

    Measured: Day 1 - 85

  12. Incidence and severity of ISRs

    Incidence, and severity of injection site reactions

    Measured: Day 1 - 85

  13. Incidence of abnormal and clinically relevant safety laboratory parameters

    Incidence of abnormal and clinically relevant safety laboratory tests including clinical chemistry, hematology, and vital signs.

    Measured: Day 1 - 85

  14. MaxELDL-C using DS from Pfizer as compared to BIP, if applicable

    Maximum lowering in LDL-C using DS manufactured by Pfizer vs. BIP, if applicable

    Measured: Day 1 - Day 85

  15. AUEClast using DS from Pfizer as compared to BIP, if applicable

    Area under the LDL-C curve using DS manufactured by Pfizer vs. BIP, if applicable

    Measured: Day 1 - Day 85

  16. MaxELDL-C using PFS as compared to PFP, if applicable

    Maximum lowering in LDL-C using prefilled syringe vs. prefilled pen , if applicable

    Measured: Day 1 - Day 85

  17. AUEClast using PFS as compared to PFP, if applicable

    Area under the LDL-C curve using prefilled syringe vs. prefilled pen , if applicable

    Measured: Day 1 - Day 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
470 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02458209
Sponsor's protocol ID
B1481026
Status last verified
Mar 2016
First submitted
1 May 2015
Last updated
8 Mar 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 37994400

  • 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.

    PubMed 29688615

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing bococizumab PFS:Pfizer, bococizumab PFS: BIP and bococizumab PFP in people with Healthy, run by Pfizer at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: Day 1 - Day 85). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02458209, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.

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