drugset / Trial / NCT03310021
A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects
RandomizedParallel-groupTriple-blindTreatment
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."
Timeline
- Start
- 2017-08-28
- Primary completion
- 2019-08-13
- Completion
- 2019-08-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Andexanet alfa | Protein / enzyme biologic | — | Intravenous |
| Subject | Apixaban | Small molecule | — | — |
| Subject | Edoxaban | Small molecule | — | — |
| Subject | Rivaroxaban | Other / unclassified | — | — |