Relationship of edoxaban plasma concentration and blood coagulation in healthy volunteers using standard laboratory tests and viscoelastic analysis (EdoRot).

Phase 1

• Conditions: Healthy volunteers; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2018-001265-17-FI
• Lead Sponsor: Turku University Central Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-06
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

1.Healthy male volunteers
2.Age of 18 - 40 years
3.Written informed consent from the participating subject

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Investigate the relationship of edoxaban plasma concentrations and the effect on blood coagulation;Primary end point(s): Correlation between edoxaban peak plasma concentrations and ROTEM ExTEM and FibTEM values;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. ;Main Objective: Evaluate the capability of viscoelastic measurement parameters to reveal changes in blood coagulation caused by an anticoagulant drug edoxaban in healthy volunteers

Secondary Outcome Measures

Name	Time	Method
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. ;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.