Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
NCT ID:
NCT01826266
Brief Summary:
PER977 monotherapy and co-administration following 60 mg edoxaban will have an acceptable safety and tolerability profile with no impact on pro-coagulant biomarkers. A dose of PER977 that reverses the effects of edoxaban on the pharmacodynamic (PD) biomarkers (point of care prothrombin time \[PoC-PT\]), and/or secondary biomarkers (thromboelastography reaction time \[TEG-R\]) will be identified.
Detailed Description:
Normal subjects will be dosed with PER977 or placebo alone and 1 week later, they will be given a single dose of edoxaban followed in 3 hours by a single IV dose of PER977. The purpose is to show safety and tolerability of PER977 alone and when combined with a NOAC (edoxaban). The study will also provide some insight into the doses that may be required to reverse a steady state edoxaban.
Study:
NCT01826266
Study Brief:
Protocol Section:
NCT01826266