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Rivaroxaban once daily · 1 trial · 1 indication
Pharamacodymic (PD) variables (ie, PT, INR, aPTT, TGA, and anti-FXa) are blood coagulation (or clotting) tests. These blood clotting tests will be performed to assess the effects of Prothrombin Complex Concentrates (PCCs) (Profilnine SD or Beriplex P/N) on the pharmacodynamics of rivaroxaban.
| Arm | Type | Description |
|---|---|---|
| Rivaroxaban + Profilnine SD | EXPERIMENTAL | Rivaroxaban 20 mg twice a day on Days 1-4 followed by rivaroxaban 20 mg once a day on Day 5 administered 4 hours before a single bolus dose of Profilnine SD 50 IU/kg. |
| Rivaroxaban + Beriplex P/N | EXPERIMENTAL | Rivaroxaban 20 mg twice a day on Days 1-4 followed by rivaroxaban 20 mg once a day on Day 5 administered 4 hours before a single bolus dose of Beriplex 50 IU/kg. |
| Rivaroxaban + Saline | EXPERIMENTAL | Rivaroxaban 20 mg twice a day on Days 1-4 followed by rivaroxaban 20 mg once a day on Day 5 administered 4 hours before a single 100cc bolus of saline. |
| Name | Type | Description |
|---|---|---|
| Rivaroxaban 20 mg twice daily | DRUG | One rivaroxaban 20 mg tablet administered twice a day (b.i.d.) for 4 days (Days 1-4). Interpretation by CTRL: Concentration type = Exact; Number = 20; unit=mg; route: oral use for 4 days. |
| Rivaroxaban 20 mg once daily | DRUG | One rivaroxaban 20 mg tablet administered once daily on Day 5. Interpretation by CTRL: Concentration type = Exact; Number = 20; unit=mg; route: oral use for 1 day. |
| Profilnine SD | DRUG | Single bolus dose of Profilnine SD 50 IU/kg administered by intravenous (IV) injection on Day 5. Interpretation by CTRL: Concentration type = Exact; Number = 50; unit=IU/kg; route: intraveous use. |
| Beriplex P/N | DRUG | Single bolus dose of Beriplex P/N 50 IU/kg administered by intravenous (IV) injection on Day 5 Interpretation by CTRL: Concentration type = Exact ; Number = 50; unit=IU/kg; route : intravenous use |
| Saline | OTHER | Single 100 cc bolus of saline administered by intravenous (IV) injection on Day 5. Interpretation by CTRL: Concentration type = Exact ; Number = 100; unit=cc; route : intravenous use use. |
Inclusion Criteria: * Have coagulation test results of PT, INR and aPTT that are within normal limits * Have a Body Mass Index (BMI; weight \[kg\]/height2 \[m\]2) between 18 and 30 kg/m2 (inclusive), and body weight between 50 and 100 kg * Have blood pressure (after the volunteer is supine \[lying ...
Rivaroxaban once daily is an investigational small molecule anticoagulant developed by Johnson & Johnson (ticker JNJ). It is being studied in a Phase 1 clinical program. Rivaroxaban once daily is also known as rivaroxaban 20 mg once daily.
Rivaroxaban once daily targets factor Xa, also known as F10, and acts as an inhibitor of this clotting enzyme. By inhibiting factor Xa, the drug is designed to reduce thrombin generation and blood clot formation.
Rivaroxaban once daily is developed by Johnson & Johnson, which trades under the ticker JNJ. Johnson & Johnson is the sponsor of the clinical program for this investigational small molecule anticoagulant.
Rivaroxaban once daily is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The program includes one completed Phase 1 trial with 35 enrolled participants.
Rivaroxaban once daily has been studied in one completed Phase 1 trial, NCT01656330, titled A Study to Assess the Effects of 2 Different Prothrombin Complex Concentrates on the Pharmacodynamics of Rivaroxaban in Healthy Adult Volunteers. The trial enrolled 35 healthy adult volunteers in Belgium and was randomized and controlled.