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Completed

NCT Number: NCT02531815

Dose Escalation Study of PF-06741086 In Healthy Subjects

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-06741086

Biological

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)

Placebo

Drug

Placebo for PF-06741086, single dose

Other names: saline placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 25, 2015
Registry last updated
Aug 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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