Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01379300 | A Study to Investigate Biomarkers After Single Doses of Anticoagulants in Healthy Young Male and Healthy Elderly Participants (MK-0000-216 AM1) | PHASE1 | COMPLETED | 42 | — | — | May 1, 2011 | Dec 1, 2011 | Oct 2, 2015 | - | — |
| 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...