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Trial record 4 of 4 for:    PF‐06741086

Dose Escalation Study of PF-06741086 In Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02531815
Recruitment Status : Completed
First Posted : August 25, 2015
Last Update Posted : August 12, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This Phase 1 first-in-human single ascending dose study will be a randomized, double-blind, placebo-controlled investigation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06741086.

Condition or disease Intervention/treatment Phase
Healthy Biological: PF-06741086 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single Intravenous Or Subcutaneous Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Pf-06741086 In Healthy Subjects And An Open-label Evaluation In Healthy Japanese Subjects
Study Start Date : August 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Arm Intervention/treatment
Experimental: Cohort 1 (subcutaneous [SC]) PF-06741086, Placebo Biological: PF-06741086
PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)

Drug: Placebo
Placebo for PF-06741086, single dose
Other Name: saline placebo

Experimental: Cohort 2 (SC) PF-06741086, Placebo Biological: PF-06741086
PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)

Drug: Placebo
Placebo for PF-06741086, single dose
Other Name: saline placebo

Experimental: Cohort 3 (SC) PF-06741086, Placebo Biological: PF-06741086
PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)

Drug: Placebo
Placebo for PF-06741086, single dose
Other Name: saline placebo

Experimental: Cohort 4 (Intravenous [IV]) PF-06741086, Placebo Biological: PF-06741086
PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)

Drug: Placebo
Placebo for PF-06741086, single dose
Other Name: saline placebo

Experimental: Cohort 5 (IV) PF-06741086, Placebo Biological: PF-06741086
PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)

Drug: Placebo
Placebo for PF-06741086, single dose
Other Name: saline placebo

Experimental: Cohort 6 (IV) PF-06741086, Placebo Biological: PF-06741086
PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)

Drug: Placebo
Placebo for PF-06741086, single dose
Other Name: saline placebo

Experimental: Cohort 7 (IV) PF-06741086, Placebo Biological: PF-06741086
PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)

Drug: Placebo
Placebo for PF-06741086, single dose
Other Name: saline placebo

Experimental: Cohort 8 (subcutaneous [SC]) PF-06741086 Biological: PF-06741086
PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)




Primary Outcome Measures :
  1. Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs [ Time Frame: Day 1 up to Day 84 ]
  2. Percentage of subjects with laboratory abnormalities [ Time Frame: Day 1 up to Day 84 ]
  3. Number of subjects with change from baseline in vital signs [ Time Frame: Day 1 up to Day 84 ]
    blood pressure, pulse rate, temperature, respiration rate

  4. Number of subjects with change from baseline in electrocardiogram (ECG) parameters [ Time Frame: Day 1 to Day 84 ]
  5. Percentage of subjects with changes from baseline in physical examination [ Time Frame: Day 1 to Day 84 ]
  6. Percentage of subjects with infusion site reactions [ Time Frame: Day 1 up to Day 7 ]
  7. Percentage of subjects with injection site reactions [ Time Frame: Day 1 to Day 7 ]

Secondary Outcome Measures :
  1. Plasma PF-06741086 concentrations [ Time Frame: Day 1 up to Day 84 ]
  2. Maximum observed plasma concentration (Cmax) [ Time Frame: Day 1 up to Day 84 ]
  3. Time for Cmax (Tmax) [ Time Frame: Day 1 up to Day 84 ]
  4. Area under the curve from time zero to last quantifiable concentration (AUClast) [ Time Frame: Day 1 up to Day 84 ]
  5. Terminal half-life (t 1/2) [ Time Frame: Day 1 up to Day 84 ]
  6. Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf) [ Time Frame: Day 1 up to Day 84 ]
  7. Volume of distribution at steady state (Vss) [ Time Frame: Day 1 up to Day 84 ]
    Intravenous administration only

  8. Apparent volume of distribution (Vz/F) [ Time Frame: Day 1 up to Day 84 ]
    Subcutaneous administration only

  9. Clearance (CL) [ Time Frame: Day 1 up to Day 84 ]
    Intravenous administration only

  10. Apparent clearance (CL/F) [ Time Frame: Day 1 up to Day 84 ]
    Subcutaneous administration only

  11. Bioavailability (F) [F = AUC (inf,sc) / AUC (inf,iv)] [ Time Frame: Day 1 up to Day 84 ]
  12. Mean residence time (MRT) [ Time Frame: Day 1 up to Day 84 ]
  13. Total tissue factor pathway inhibitor concentrations over time [ Time Frame: Day 1 up to Day 84 ]
  14. Thrombin generation [ Time Frame: Day 1 up to Day 84 ]
    may include lag time, peak thrombin generation, and endogenous thrombin generation potential

  15. Prothrombin fragment 1+2 (PF1+2) concentrations over time [ Time Frame: Day 1 up to Day 84 ]
  16. D-dimer concentrations over time [ Time Frame: Day 1 up to Day 84 ]
  17. Dilute prothrombin time (dPT) [ Time Frame: Day 1 up to Day 84 ]
  18. Frequency of anti-drug antibody (ADA) and neutralizing antibody (NAb) production [ Time Frame: Day 1 up to Day 84 ]
    Immunogenicity



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs) and 100 kg (220 lbs).

Exclusion Criteria:

  • Increased risk of thrombosis (coronary artery disease, hypercholesterolemia, diabetes)
  • Use of nicotine/tobacco products
  • Clotting disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531815


Locations
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Belgium
Pfizer Clinical Research Unit
Brussels, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02531815     History of Changes
Other Study ID Numbers: B7841001
2015-001821-17 ( EudraCT Number )
First Posted: August 25, 2015    Key Record Dates
Last Update Posted: August 12, 2016
Last Verified: August 2016
Keywords provided by Pfizer:
safety
tolerability
pharmacokinetics
pharmacodynamics
Phase 1
first in human
monoclonal antibody
tissue factor pathway inhibitor
japanese