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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-002194-31 | EudraCT Number |
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The primary objective of this study is to evaluate whether ASA and darexaban which have different effects on blood coagulation influence each other in their effects. Also it will be investigated whether the blood levels of either drug are influenced by the presence of the other drug. In addition, the safety and tolerability of each drug and the combination of the drugs will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm 1 | Experimental | darexaban, wash-out, ASA, wash-out, darexaban plus ASA |
|
| Treatment arm 2 | Experimental | darexaban, wash-out, darexaban plus ASA, wash-out, ASA |
|
| Treatment arm 3 | Experimental | ASA, wash-out, darexaban, wash-out, darexaban plus ASA |
|
| Treatment arm 4 | Experimental | ASA, wash-out, darexaban plus ASA, wash-out, darexaban |
|
| Treatment arm 5 | Experimental | darexaban plus ASA, wash-out, darexaban, wash-out, ASA |
|
| Treatment arm 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darexaban | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite assessment of pharmacodynamics of darexaban and darexaban glucuronide | Assessment includes skin bleeding time, factor Xa, platelet aggregation, thromboxane B2 synthesis, PT & aPTT | Baseline and after six days of dosing of darexaban, ASA, or a combination of the two |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of darexaban and darexaban glucuronide assessed by plasma concentration | Plasma samples are taken until 24 hours after six days of dosing of darexaban, or the combination with ASA | |
| Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Study Manager | Astellas Pharma Europe B.V. | Study Chair |
| Principal Investigator | SGS Aster, Paris, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Aster | Paris | 75015 | France |
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| ID | Term |
|---|---|
| C569750 | darexaban |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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darexaban plus ASA, wash-out, ASA, wash-out, darexaban |
|
|
| Acetyl Salicylic Acid (ASA) | Drug | oral |
|
|
| 6 days for each of the 3 treatment periods |
| Pharmacokinetics of ASA assessed by plasma concentration | Plasma samples are taken until 2 hours after six days of dosing of ASA, or the combination with darexaban |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |