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

NCT04832139 | Terminated Phase 1 FDA Drug

• 2 other identifiers: B78410092020-004369-38
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Bioequivalence; Phase 1; Prefilled Pen; Prefilled syringe; pharmacokinetic; subcutaneous; hemophilia

Outcome Measures

Primary Outcomes (2)

• Area Under the plasma concentraiton time Curve from time zero extrapolated to infinite time (AUCinf)

  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)

  Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose

Secondary Outcomes (10)

• Area under the concentration time curve from time 0 to time of last quatifiable concenteration

  Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose

• Time for Cmax

  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

  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

  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

  Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose

Study Arms (2)

Marstacimab Prefilled Pen (PFP), then marstacimab Preflled Syringe (PFS)

EXPERIMENTAL

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; Drug: Marstacimab PFS

Marstacimab PFS, then marstacimab PFP

EXPERIMENTAL

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; Drug: Marstacimab PFS

Interventions

Marstacimab PFP DRUG

300 milligrams (mg) subcutaneous injection marstacimab PFP

Also known as: PF-06741086

Marstacimab PFS, then marstacimab PFP; Marstacimab Prefilled Pen (PFP), then marstacimab Preflled Syringe (PFS)

Marstacimab PFS DRUG

300 mg subcutaneous injection of marstacimab PFS

Also known as: PF-06741086

Marstacimab PFS, then marstacimab PFP; Marstacimab Prefilled Pen (PFP), then marstacimab Preflled Syringe (PFS)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Brussels Clinical Research Unit

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Location

Related Links

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

MeSH Terms

Conditions

Hemophilia A

Interventions

marstacimab

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 5, 2021
• Study Start: March 30, 2021
• Primary Completion: November 22, 2021
• Study Completion: November 22, 2021
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)