Healthy Clinical Trial
Official title:
Phase 2 Placebo-Controlled, Single-Site, Single-Blind Study of Rivaroxaban Reversal by Ciraparantag as Measured by WBCT
This study is a randomized, single-blind, placebo-controlled study to assess the efficacy and safety of ciraparantag administered to healthy volunteers anticoagulated with rivaroxaban measuring clotting times using Whole Blood Clotting Time (WBCT).
This is a randomized, single-blind, placebo-controlled assessment of the efficacy and safety
of ciraparantag administered to healthy volunteers measuring clotting times using WBCT as
determined by the manual testing method. All subjects will undergo screening up to 36 days
prior to enrollment.
All enrolled subjects are to receive a single dose of 20 mg rivaroxaban in the morning on
Days 1-3. On Day 3 (3.75 hours post rivaroxaban), subjects who have a minimum increase in
clotting time of 25% (as measured by WBCT) are randomized and will receive a single IV dose 4
hours after the rivaroxaban dose, followed by serial testing of manual WBCT.
Subjects are enrolled sequentially in up to 4 ciraparantag dose cohorts. There will be a
safety review after completion of treatment in one cohort and prior to initiation of
treatment in the subsequent cohort.
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