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

Portola Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Biological: PRT064445

Study type: Interventional

Funder types: Industry

Identifiers

NCT03218241

11-501

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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32 participants in 5 patient groups

PRT0064445 Dose 1

Experimental group

Description:

Dose 1 versus Placebo

Treatment:

Biological: PRT064445

Drug: Placebo

PRT064445 Dose 2

Experimental group

Description:

Dose 2 versus Placebo

Treatment:

Biological: PRT064445

Drug: Placebo

PRT064445 Dose 3

Experimental group

Description:

Dose 3 versus Placebo

Treatment:

Biological: PRT064445

Drug: Placebo

PRT064445 Dose 4

Experimental group

Description:

Dose 4 versus Placebo

Treatment:

Biological: PRT064445

Drug: Placebo

PRT064445 Dose 5

Experimental group

Description:

Dose 5 versus Placebo

Treatment:

Biological: PRT064445

Drug: Placebo