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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: Completed Phase 1 study, sponsored by Portola Pharmaceuticals.
NCT03083704 is a Phase 1 study that has completed, run by Portola Pharmaceuticals. The registered enrollment target is 153 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (155% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To evaluate the pharmacokinetics of Generation 2 process andexanet, as measured by AUC(0-∞)
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 |
What the finished NCT03083704 record still lists
NCT03083704 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (155% higher).
The record links to 0 conditions, and to 5 interventions - of which Enoxaparin sodium is the first listed.
NCT03083704 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03083704's enrollment target sits among peer trials
153 358th of 2000 higher than 1,642 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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