Trials / Completed
CompletedNCT03310021
A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Andexanet Alfa Administered to Healthy Japanese and Caucasian Subjects
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 108 (actual)
- Sponsor
- Portola Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
"This is a single-center, randomized, double-blind, and placebo-controlled trial designed to: 1) demonstrate the degree to which administered andexanet doses can reverse Factor Ten A (FXa)-inhibitor induced anticoagulation; and 2) evaluate the safety and PK/PD of andexanet in healthy Japanese subjects taking direct FXa inhibitors at therapeutic doses."
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Andexanet alfa | fXa inhibitor antidote |
| DRUG | Apixaban | factor Xa inhibitor |
| DRUG | Rivaroxaban | factor Xa inhibitor |
| DRUG | Edoxaban | factor Xa inhibitor |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2017-08-28
- Primary completion
- 2019-08-13
- Completion
- 2019-08-13
- First posted
- 2017-10-16
- Last updated
- 2023-02-24
- Results posted
- 2020-08-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03310021. Inclusion in this directory is not an endorsement.