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OpenTrials
Completed

NCT Number: NCT01897142

A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Volunteers

The purpose of this study is to determine what the study drug does to the body, what the body does to the study drug, and if the study drug is safe and well tolerated when given to adult healthy volunteers.

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

All sexes

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

  • Healthy male subjects.
  • Healthy non-child bearing female subjects.
  • 18 to 35 years of age.

Exclusion criteria

  • Heart disease.
  • Clotting disorders.
  • Use of nicotine products.
  • Diabetes.

Treatment and study plan

PF-05230907

Biological

0.1 micrograms per kilogram of PF-05230907, IV bolus, single dose

Placebo for PF-05230907

Drug

0.1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose

Primary outcomes

  1. Incidence of dose limiting treatment related adverse events

    Time frame: Through Day 43

  2. Incidence, severity and causal relationship of treatment emergent adverse events, treatment emergent serious adverse events, and withdrawals due to treatment emergent adverse events

    Time frame: Through Day 43

  3. Incidence and magnitude of treatment emergent abnormal laboratory findings

    Time frame: Through Day 43

  4. Change from baseline in vital sign measurements, ECG parameters, and physical examinations

    Time frame: Through Day 43

Secondary outcomes

  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Time frame: Through 4 hour post dose Day 1

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Through 4 hour post dose Day 1

  3. Pharmacodynamic activity as measured by prothrombin time/internationalize normalized ration (PT/INR)

    Time frame: Through post dose Day3

  4. Pharmacodynamic activity as measured by activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT)

    Time frame: Through post dose Day3

  5. Pharmacodynamic activity as measured by thrombin-antithrombin (TAT) complexes

    Time frame: Through post dose Day 2

  6. Pharmacodynamic activity as measured by prothrombin fragments 1+2 (PF1+2)

    Time frame: Through post dose Day 2

  7. Pharmacodynamic activity as measured by D-dimer

    Time frame: Through post dose Day 7

  8. Pharmacodynamic activity as measured by protein C activity

    Time frame: Through post dose Day 2

  9. Pharmacodynamic activity as measured by Factor V activity

    Time frame: Through post dose Day 3

  10. Incidence of antibody immune response

    Time frame: Through post dose Day 43

  11. Factor X activity

    Time frame: Through post dose Day 43

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Subjects

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 11, 2013
Registry last updated
Apr 22, 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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