drugset / Trial / NCT03083704
A Healthy Volunteer PK/PD, Safety and Tolerability Study of Second Generation Andexanet Alfa
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2017-02-26
- Primary completion
- 2017-09-28
- Completion
- 2017-09-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Andexanet alfa | Protein / enzyme biologic | — | — |
| Background | Apixaban | Small molecule | 5 mg | — |
| Background | Apixaban | Small molecule | 10 mg | — |
| Background | Edoxaban | Small molecule | 60 mg | — |
| Background | Enoxaparin sodium | Other / unclassified | — | — |
| Background | Rivaroxaban | Other / unclassified | 10 mg | — |
| Background | Rivaroxaban | Other / unclassified | 20 mg | — |