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

Portola Pharmaceuticals32 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

PRT064445BIOLOGICAL

Intravenous

PlaceboDRUG

Intravenous to mimic PRT064445

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Pharmacodynamics assessments

Time frame: Up to 28 days

Secondary Outcomes

Pharmacokinetics: Plasma levels of PRT064445

Time frame: Up to 7 days

Data from ClinicalTrials.gov

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