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NCT03083704 · ClinicalTrials.gov registry record · Phase 1
A Healthy Volunteer PK/PD, Safety and Tolerability Study of Second Generation Andexanet Alfa
A Phase 1 study, sponsored by Portola Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 153
- Enrollment target
NCT03083704 is a Phase 1 study that has completed, run by Portola Pharmaceuticals. The registered enrollment target is 153 participants.
The verdict
NCT03083704, a Phase 1 study, has completed, sponsored by Portola Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 153 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, study in healthy volunteers dosed to steady state with fXa inhibitors, designed to (1) demonstrate PK/PD comparability between andexanet manufactured by the Generation 1 and Generation 2 processes, (2) evaluate the degree to which the Generation 2 andexanet reverses fXa-inhibitor-induced anticoagulation in comparison to placebo, and (3) evaluate safety of Generation 2 andexanet.
Interventions
- DRUG Enoxaparin sodium
- BIOLOGICAL Andexanet alfa (Gen 1 Process 2)
- DRUG Apixaban 5 MG
- DRUG Rivaroxaban 20 MG
- DRUG Edoxaban 60 MG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2017-02-26 |
| Est. Completion | 2017-09-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03083704
The ClinicalTrials.gov registry entry for NCT03083704 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 153 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 5 interventions - of which Enoxaparin sodium is the first listed.
NCT03083704 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03083704 about?
NCT03083704 is a clinical study titled "A Healthy Volunteer PK/PD, Safety and Tolerability Study of Second Generation Andexanet Alfa". This is a randomized, double-blind, study in healthy volunteers dosed to steady state with fXa inhibitors, designed to (1) demonstrate PK/PD comparability between andexanet manufactured by the Generation 1 and Generation 2 processes, (2) evaluate the degree to which the Generation 2 andexanet revers...
What is the current status of trial NCT03083704?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 153 participants. The study started on 2017-02-26. Estimated completion is 2017-09-28.
What interventions are being tested in trial NCT03083704?
The interventions under investigation include: Enoxaparin sodium (DRUG), Andexanet alfa (Gen 1 Process 2) (BIOLOGICAL), Apixaban 5 MG (DRUG), Rivaroxaban 20 MG (DRUG), Edoxaban 60 MG (DRUG).
Who is sponsoring clinical trial NCT03083704?
This trial is sponsored by Portola Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
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