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

July 7, 2022 updated by: Pfizer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Bruxelles-capitale, Région DE
      • Brussels, Bruxelles-capitale, Région DE, Belgium, B-1070
        • Brussels Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Marstacimab PFP
300 milligrams (mg) subcutaneous injection marstacimab PFP
Other Names:
  • PF-06741086
Drug: Marstacimab PFS
300 mg subcutaneous injection of marstacimab PFS
Other Names:
  • PF-06741086
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.
Drug: Marstacimab PFP
300 milligrams (mg) subcutaneous injection marstacimab PFP
Other Names:
  • PF-06741086
Drug: Marstacimab PFS
300 mg subcutaneous injection of marstacimab PFS
Other Names:
  • PF-06741086

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Area Under the plasma concentraiton time Curve from time zero extrapolated to infinite time (AUCinf)
Time Frame: Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose
Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose
Maximum observed plasma concentration (Cmax)
Time Frame: Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose
Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Area under the concentration time curve from time 0 to time of last quatifiable concenteration
Time Frame: Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose
Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose
Time for Cmax
Time Frame: Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose
Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose
Apparent clearance after subcutaneous dose
Time Frame: Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose
Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose
Apparent volume of distribution after subcutaneous dose
Time Frame: Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose
Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose
Terminal half-life after subcutaneous dose
Time Frame: Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose
Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose
Incidence of clinically significant laboratory value abnormalities
Time Frame: Baseline through the end of study, approximately 161 days
Baseline through the end of study, approximately 161 days
Incidence of anti-drug antibody against marstacimab
Time Frame: From Day 1, Period 1 through Day 21, Period 4 over a total of 84 days
From Day 1, Period 1 through Day 21, Period 4 over a total of 84 days
Incidence of Adverse Events
Time Frame: Baseline through the end of study, approximately 161 days
Baseline through the end of study, approximately 161 days
Incidence of neutralizing antibody against marstacimab
Time Frame: From Day 1, Period 1 through Day 21, Period 4 over a total of 84 days
From Day 1, Period 1 through Day 21, Period 4 over a total of 84 days
Incidence of Serious Adverse Events
Time Frame: Baseline through the end of study, approximately 161 days
Baseline through the end of study, approximately 161 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 22, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B7841009
  • 2020-004369-38 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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