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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: PRT064445; Drug: Placebo

• Registration Number: NCT03218241
• Lead Sponsor: Portola Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2012-09
• Study Completion: 2012-10
• Study First Submitted: 2012-12-27
• Study First Submitted QC: 2017-07-12
• Study First Posted: 2017-07-14
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PRT064445 Dose 2	Placebo	Dose 2 versus Placebo
PRT064445 Dose 3	PRT064445	Dose 3 versus Placebo
PRT064445 Dose 5	Placebo	Dose 5 versus Placebo
PRT064445 Dose 2	PRT064445	Dose 2 versus Placebo
PRT0064445 Dose 1	PRT064445	Dose 1 versus Placebo
PRT064445 Dose 3	Placebo	Dose 3 versus Placebo
PRT0064445 Dose 1	Placebo	Dose 1 versus Placebo
PRT064445 Dose 4	Placebo	Dose 4 versus Placebo
PRT064445 Dose 5	PRT064445	Dose 5 versus Placebo
PRT064445 Dose 4	PRT064445	Dose 4 versus Placebo

Primary Outcome Measures

Name	Time	Method
Pharmacodynamics assessments	Up to 28 days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Plasma levels of PRT064445	Up to 7 days