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NCT03218241 Clinical Trial

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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03218241
Other study ID # 11-501
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 2012
Est. completion date October 2012

Study information
Verified date August 2023
Source Alexion
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date October 2012
Est. primary completion date September 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• PRT064445
Intravenous
Drug:
• Placebo
Intravenous to mimic PRT064445

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Portola Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacodynamics assessments Up to 28 days
Secondary Pharmacokinetics: Plasma levels of PRT064445 Up to 7 days
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