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OpenTrials
Completed

NCT Number: NCT03218241

Single Ascending Dose Study of PRT064445, a Factor Xa (fXa) Inhibitor Antidote

This is a single center, double-blind, randomized, placebo-controlled, ascending, single dose study of PRT064445 or its matching placebo, in healthy subjects.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Phoenix, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy men or women between the ages of 18 and 50 years old, inclusive
  • BMI 19-32 and weighs at least 60kgs

Exclusion criteria

  • History or symptoms of bleeding problems or thrombotic conditions
  • Clinically significant medical history
  • Major surgery, severe trauma, or bone fracture within 3 months

Treatment and study plan

PRT064445

Biological

Intravenous

Placebo

Drug

Intravenous to mimic PRT064445

Other names: Placebo (for PRT064445)

Primary outcomes

  1. Pharmacodynamics assessments

    Time frame: Up to 28 days

Secondary outcomes

  1. Pharmacokinetics: Plasma levels of PRT064445

    Time frame: Up to 7 days

Sponsors and collaborators

Lead sponsor

Portola Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered PRT064445, a Factor Xa (fXa) Inhibitor Antidote

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 14, 2017
Registry last updated
Aug 4, 2023

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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