CClinicalTrials.gg
CompletedNCT03218241Updated Aug 4, 2023

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

A Phase 1 interventional study of PRT064445 and Placebo in Healthy, sponsored by Portola Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-04.

Sponsored by Portola Pharmaceuticals · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy

Keywords

  • Healthy Volunteers
03

In context

Lead sponsor

Portola Pharmaceuticals is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    PRT0064445 Dose 1

    Dose 1 versus Placebo

    Biological: PRT064445 · Drug: Placebo

  • Experimental
    PRT064445 Dose 2

    Dose 2 versus Placebo

    Biological: PRT064445 · Drug: Placebo

  • Experimental
    PRT064445 Dose 3

    Dose 3 versus Placebo

    Biological: PRT064445 · Drug: Placebo

  • Experimental
    PRT064445 Dose 4

    Dose 4 versus Placebo

    Biological: PRT064445 · Drug: Placebo

  • Experimental
    PRT064445 Dose 5

    Dose 5 versus Placebo

    Biological: PRT064445 · Drug: Placebo

Interventions

  • BiologicalPRT064445

    Intravenous

  • DrugPlacebo

    Intravenous to mimic PRT064445

    Also known as: Placebo (for PRT064445)

06

What researchers measure

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

07

Study locations

1 site
  • Phoenix, Arizona 85283, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03218241
Lead sponsor
Portola Pharmaceuticals
Responsible party
Sponsor
First posted
Jul 14, 2017
Start date
Jun 2012
Primary completion
Sep 2012
Completion
Oct 2012
Last update
Aug 4, 2023

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion