Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
rivaroxaban · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Dabigatran | EXPERIMENTAL | Single 150-mg dose of dabigatran etexilate |
| Rivaroxaban | EXPERIMENTAL | Single 20-mg dose of rivaroxaban |
| No intervention | NO_INTERVENTION | No study drug will be administered |
| Name | Type | Description |
|---|---|---|
| dabigatran etexilate | DRUG | dabigatran etexilate, orally, as 2 x 75-mg capsules (150 mg), single administration |
| rivaroxaban | DRUG | rivaroxaban, orally, as 2 x 10-mg tablets (20 mg), single administration |
Inclusion criteria for non-hemophilia participants: Panel A \- Male or female between 65 to 85 years of age Panel B \- Male between 18 to 45 years of age Both Panels * Weight of ≥50 kg and ≤110 kg * In good health * No clinically significant abnormality on electrocardiogram (ECG) * Nonsmoker a...
Rivaroxaban is a small molecule drug being investigated for the treatment of thrombosis, a condition involving blood clots. It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers to assess biomarkers after single doses, with the goal of understanding its effects in this cardiovascular indication.
Rivaroxaban is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and biomarker effects in healthy participants. Merck is responsible for the ongoing research and development of this investigational therapy for thrombosis.
Rivaroxaban is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied in a single Phase 1 trial that has been completed, involving healthy volunteers to evaluate biomarkers after single doses of the anticoagulant.
Rivaroxaban has one completed Phase 1 clinical trial registered under NCT01379300. The trial, titled 'A Study to Investigate Biomarkers After Single Doses of Anticoagulants in Healthy Young Male and Healthy Elderly Participants (MK-0000-216 AM1)', enrolled 42 participants. The study was not double-blinded and used a no-treatment controlled design.
Rivaroxaban is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug has completed one Phase 1 trial, but it remains under study and has not received regulatory approval for the treatment of thrombosis. Further clinical trials would be needed to establish its safety and efficacy.
Rivaroxaban is an anticoagulant, a type of drug that helps prevent blood clots. It is being studied for its effects on biomarkers related to thrombosis. The drug is administered as a small molecule and is being evaluated in healthy volunteers to understand its pharmacological effects in the body.