Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
rivaroxaban once daily 8 days · 1 trial · 2 indications
Rivaroxaban plasma concentrations was assessed by the reference method at the different sampling points to determine the area under the curve (AUC)
Cmax of rivaroxaban was assessed
Tmax of rivaroxaban was assessed
| Arm | Type | Description |
|---|---|---|
| morbidly obese patients with BMI ≥ 40 | EXPERIMENTAL | Morbidly obese patients with BMI ≥ 40 |
| Patients operated by gastric bypass | EXPERIMENTAL | Patients operated by gastric bypass for over a year and with stable weight |
| Patients operated by sleeve gastrectomy | EXPERIMENTAL | Patients operated by sleeve gastrectomy for over a year and with stable weight |
| Control group: non-operated subjects | EXPERIMENTAL | Control group: non-operated subjects but with an age and a BMI corresponding to those of the patients of the 2 operated groups. |
| Name | Type | Description |
|---|---|---|
| rivaroxaban 20 mg once daily 8 days | DRUG | Blood samples for the measurement of rivaroxaban PK parameters |
Inclusion Criteria: * Creatinine clearance measured by the Cockroft formula ≥ 60 mL / min * Patient meeting the specific criteria of one of the 4 groups: * morbidly obese patients with BMI ≥ 40 * Patients operated by gastric bypass for over a year and with stable weight * Patients operated by sleev...
Rivaroxaban once daily 8 days refers to an eight-day course of rivaroxaban 20 mg taken once daily. It is being studied in a Phase 1 trial in people who have had bariatric surgery, a population where drug absorption may be altered. Rivaroxaban is a small-molecule factor Xa inhibitor developed by Bayer AG.
It is being evaluated in bariatric surgery patients, including those with morbid obesity, to study the pharmacokinetics of rivaroxaban after surgery. The Phase 1 trial NCT04180436 examined how the body processes an eight-day once-daily 20 mg regimen in this population. It is investigational for this setting and is not approved for this use.
Rivaroxaban targets factor Xa, also known as F10, and acts as an inhibitor of this clotting enzyme. By inhibiting factor Xa, it reduces thrombin generation and blood clot formation. This mechanism underlies its study in the bariatric surgery population, where anticoagulation management can be challenging.
Bayer AG develops rivaroxaban, traded on the OTC market under the ticker BAYRY. Bayer is the sponsor of the Phase 1 pharmacokinetic study of the once-daily 8-day regimen in bariatric surgery patients. Rivaroxaban is a small-molecule factor Xa inhibitor.
Rivaroxaban once daily 8 days is in Phase 1 development. The single trial, NCT04180436, has been completed and enrolled 67 participants. It is an investigational regimen in this specific bariatric surgery setting and is not approved for this indication.
The regimen has been studied in one completed Phase 1 trial, NCT04180436, titled Pharmacokinetics of Rivaroxaban After Bariatric Surgery. The trial enrolled 67 participants in France, included adults 18 years and older of all sexes, and allowed healthy volunteers. It used a controlled design without randomization or double blinding.