Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rivaroxaban twice 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 twice daily is an investigational small molecule being studied in healthy adult volunteers. It is being evaluated for its pharmacodynamic effects when combined with different prothrombin complex concentrates. The drug is not approved for any indication and remains in clinical development.
Rivaroxaban twice daily is being developed by Johnson & Johnson, traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical research on this small molecule drug in healthy volunteers.
Rivaroxaban twice daily is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in healthy adult volunteers to assess its pharmacodynamic effects.
Rivaroxaban twice daily has one completed clinical trial, NCT01656330, titled 'A Study to Assess the Effects of 2 Different Prothrombin Complex Concentrates on the Pharmacodynamics of Rivaroxaban in Healthy Adult Volunteers.' This Phase 1 study enrolled 35 participants in Belgium and was a randomized, controlled trial.
Rivaroxaban twice daily refers to a specific dosing regimen of the drug rivaroxaban. The clinical trial NCT01656330 studies the pharmacodynamics of rivaroxaban when administered twice daily in healthy volunteers, comparing the effects of two different prothrombin complex concentrates.