E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Blood and lymphatic diseases [C15] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluate the capability of viscoelastic measurement parameters to reveal changes in blood coagulation caused by an anticoagulant drug edoxaban in healthy volunteers |
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E.2.2 | Secondary objectives of the trial |
Investigate the relationship of edoxaban plasma concentrations and the effect on blood coagulation |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Healthy male volunteers 2. Age of 18 - 40 years 3. Written informed consent from the participating subject
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E.4 | Principal exclusion criteria |
1. A previous history of intolerance to the study drug or related compounds and additives 2. History of bleeding disorder or similar 3. History of alcoholism, drug abuse, psychiatric, psychological or other emotional problems that are likely to invalidate informed consent 4. BMI ≤ 20 or ≥ 35 5. Concomitant drug therapy of any kind for at least 14 days prior to the study 6. Existing or recent significant disease 7. A “yes” answer to any one of the Abuse Questions. 8. Donation of blood for 4 weeks prior and during the study. 9. Special diet or life style conditions which would compromise the conditions of the study or interpretation of the results. Drinking grapefruit juice and eating grapefruits is forbidden one week before the research and during the research itself. 10. Participation in any other studies involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study. 11. Smoking for one month before the start of the study and during the whole study period.
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E.5 End points |
E.5.1 | Primary end point(s) |
Correlation between edoxaban peak plasma concentrations and ROTEM ExTEM and FibTEM values |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Just before the oral administration of edoxaban 60 mg and 2 h, 4 h, 6 h, 8 h and 24 h after administration. |
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E.5.2 | Secondary end point(s) |
The association of edoxaban plasma concentrations and the effect on blood coagulation laboratory parameters P-APTT, P-TT, P-antiFXa, P-thrombin time. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Just before the oral administration of edoxaban 60 mg and 2 h, 4 h, 6 h, 8 h and 24 h after administration. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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24 hours after administration of IMP |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |