A Study of Marstacimab to Compare Prefilled Pen (PFP) Device to Prefilled Syringe (PFS) Device

NCT04832139

Last updated date
Study Location
Brussels Clinical Research Unit
Brussels, Bruxelles-capitale, Région DE, B-1070, Belgium
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male participants who are overtly healthy as determined by medical evaluation

- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

- BMI of 17.5 to 30.5 kg/m2; and a total body weight ≥ 50 kg (110 lb).

- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological,
dermatological, or allergic disease


- Any condition possibly affecting drug absorption (eg, conditions affecting SC
administration)


- Previous or current treatment for and/or history of coronary artery diseases, venous
or arterial thrombosis, or ischemic disease.


- History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV,
HBsAg, HBcAb or HCVAb


- Other medical or psychiatric condition including recent (within the past year) or
active suicidal ideation/behavior, laboratory abnormality or COVID-19 related
condition that may increase the risk of study participation or, in the investigator's
judgment, make the participant inappropriate for the study


- Use of prescription or nonprescription drugs and dietary and herbal supplements within
7 days or 5 half-lives (whichever is longer) prior to the first dose of study
intervention


- Previous administration with an investigational drug within 30 days (or as determined
by the local requirement) or 5 half-lives preceding the first dose of study
intervention used in this study (whichever is longer).


- A positive urine drug test at screening and/or admission


- Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic)


- Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may
affect participant safety or interpretation of study results


- Participants with ANY of the following abnormalities in clinical laboratory tests at
screening:


- AST or ALT level ≥1.5 × ULN;


- Total bilirubin level ≥1.5 × ULN.


- An estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m2 based on the
CKD-EPI equation.


- Resistance to activated protein C (or Factor V Leiden mutation), prothrombin 20210
mutation, antithrombin III deficiency, protein C deficiency, or protein S deficiency.


- Presence of Lupus anticoagulant anti-cardiolipin antibodies (IgG, IgM or IgA)


- High sensitivity C-reactive protein (hsCRP) above the upper limits of normal


- Abnormal hematology values as defined by the following laboratory tests at Screening
and/or admission:


- Platelet count <100,000/uL


- Hemoglobin level <10 g/dL


- A positive COVID-19 test.


- History of alcohol abuse or binge drinking and/or any other illicit drug use or
dependence within 6 months of Screening


- Use of tobacco/nicotine containing products in excess of the equivalent of 5
cigarettes/day


- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing.


- Unwilling or unable to comply with the criteria in the Lifestyle Considerations
section of the protocol


- Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective
family members

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[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of Marstacimab to Compare Prefilled Pen (PFP) Device to Prefilled Syringe (PFS) Device
Official Title  ICMJE A PHASE 1, OPEN-LABEL, RANDOMIZED, 4-PERIOD, 2-SEQUENCE, CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF MARSTACIMAB (PF-06741086) PREFILLED SYRINGE DEVICE AND PREFILLED PEN DEVICE FOLLOWING SUBCUTANEOUS ADMINISTRATION IN HEALTHY ADULT MALE PARTICIPANTS
Brief Summary The goal in this study is to show that there are not significant differences in biologic activity of the study drug when administered using either the prefilled pen and prefilled syringe.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Marstacimab PFP
    300 milligrams (mg) subcutaneous injection marstacimab PFP
    Other Name: PF-06741086
  • Drug: Marstacimab PFS
    300 mg subcutaneous injection of marstacimab PFS
    Other Name: PF-06741086
Study Arms  ICMJE
  • Experimental: Marstacimab Prefilled Pen (PFP), then marstacimab Preflled Syringe (PFS)
    Participants will first receive single dose PFP, then PFS, then repeating single dose PFP, then single dose PFS with a minimum of 21 days between single doses.
    Interventions:
    • Drug: Marstacimab PFP
    • Drug: Marstacimab PFS
  • Experimental: Marstacimab PFS, then marstacimab PFP
    Participants will first receive single dose PFS, then PFP, then repeating single dose PFS, then single dose PFP with a minimum of 21 days between single doses.
    Interventions:
    • Drug: Marstacimab PFP
    • Drug: Marstacimab PFS
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 2, 2021)
38
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 15, 2021
Estimated Primary Completion Date November 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male participants who are overtly healthy as determined by medical evaluation
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • BMI of 17.5 to 30.5 kg/m2; and a total body weight ? 50 kg (110 lb).
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease
  • Any condition possibly affecting drug absorption (eg, conditions affecting SC administration)
  • Previous or current treatment for and/or history of coronary artery diseases, venous or arterial thrombosis, or ischemic disease.
  • History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBcAb or HCVAb
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior, laboratory abnormality or COVID-19 related condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
  • Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention
  • Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
  • A positive urine drug test at screening and/or admission
  • Screening supine BP ?140 mm Hg (systolic) or ?90 mm Hg (diastolic)
  • Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
  • Participants with ANY of the following abnormalities in clinical laboratory tests at screening:

    • AST or ALT level ?1.5 × ULN;
    • Total bilirubin level ?1.5 × ULN.
  • An estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m2 based on the CKD-EPI equation.
  • Resistance to activated protein C (or Factor V Leiden mutation), prothrombin 20210 mutation, antithrombin III deficiency, protein C deficiency, or protein S deficiency.
  • Presence of Lupus anticoagulant anti-cardiolipin antibodies (IgG, IgM or IgA)
  • High sensitivity C-reactive protein (hsCRP) above the upper limits of normal
  • Abnormal hematology values as defined by the following laboratory tests at Screening and/or admission:

    • Platelet count <100,000/uL
    • Hemoglobin level <10 g/dL
  • A positive COVID-19 test.
  • History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening
  • Use of tobacco/nicotine containing products in excess of the equivalent of 5 cigarettes/day
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
  • Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of the protocol
  • Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021Cl[email protected]
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04832139
Other Study ID Numbers  ICMJE B7841009
2020-004369-38 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP