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NCT03330457 · ClinicalTrials.gov registry record · Phase 2
A Healthy Volunteer PK/PD, Safety and Tolerability Study of Andexanet After Betrixaban Dosing
A Phase 2 study, sponsored by Portola Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT03330457 is a Phase 2 study that was terminated before completion, run by Portola Pharmaceuticals. The registered enrollment target is 18 participants.
The verdict
NCT03330457, a Phase 2 study, was terminated before completion, sponsored by Portola Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, single center study in healthy volunteers dosed to steady state with betrixaban, designed to (1) Determine an andexanet dosing regimen required to reverse anticoagulant activity of betrixaban in healthy subjects, (2) Assess the safety and tolerability of andexanet vs. placebo (3) Determine the PK properties of andexanet and betrixaban (4) Determine the PD properties of betrixaban before, during, and after receiving andexanet or placebo and (5) Investigate the immunogenicity of andexanet in the presence of betrixaban.
Interventions
- BIOLOGICAL Andexanet alfa (bolus)
- DRUG Betrixaban 80 mg PO QD
- BIOLOGICAL Andexanet alfa (infusion IV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2015-08-06 |
| Est. Completion | 2016-02-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03330457
The ClinicalTrials.gov registry entry for NCT03330457 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Portola Pharmaceuticals, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Andexanet alfa (bolus) is the first listed.
NCT03330457 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03330457 about?
NCT03330457 is a clinical study titled "A Healthy Volunteer PK/PD, Safety and Tolerability Study of Andexanet After Betrixaban Dosing". This is a randomized, double-blind, single center study in healthy volunteers dosed to steady state with betrixaban, designed to (1) Determine an andexanet dosing regimen required to reverse anticoagulant activity of betrixaban in healthy subjects, (2) Assess the safety and tolerability of andexanet...
What is the current status of trial NCT03330457?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2015-08-06. Estimated completion is 2016-02-22.
What interventions are being tested in trial NCT03330457?
The interventions under investigation include: Andexanet alfa (bolus) (BIOLOGICAL), Betrixaban 80 mg PO QD (DRUG), Andexanet alfa (infusion IV) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03330457?
This trial is sponsored by Portola Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
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