Status:
COMPLETED
A Trial to Learn How Much Rivaroxaban Gets Into the Blood When Taken in Different Forms and How Safe They Are in Healthy Men
Lead Sponsor:
Bayer
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
Researchers are looking for a better way to treat venous thromboembolic disease, also known as VTE. In people with VTE, blood clots form in the veins of the legs, groin, or arms. These clots or a piec...
Eligibility Criteria
Inclusion
- Healthy male subjects.
- Age: 18 to 55 years (inclusive) at the screening examination/visit.
- Race: White (Note: Clinical Data Interchange Standards Consortium definition of White: Denotes a person with European, Middle Eastern, or North African ancestral origin who identifies, or is identified, as White (Food and Drug Administration \[FDA\]).
- Body mass index (BMI): above/equal 18 and below/equal 29.9 kg/m2.
- Ability to understand and follow instructions.
Exclusion
- Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- Known or suspected liver disorders and bile secretion/flow
- Subjects with thyroid disorders as evidenced by assessment of thyroid stimulating hormone (TSH) levels outside the normal reference range at screening
- Personal or familial history of genetically muscular diseases
- Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
- Known severe allergies e.g. allergies to more than 3 allergens, allergies affecting the lower respiratory tract- allergic asthma, allergies requiring therapy with corticosteroids, urticaria) or significant non-allergic drug reactions
- Known disorders with increased bleeding risk (e.g., periodontosis, hemorrhoids, acute gastritis, peptic ulcer)
- Known sensitivity to common causes of bleeding (e.g. nasal)
- Clinically relevant findings in the electrocardiogram (ECG) such as a second- or third-degree atrioventricular (AV) block, prolongation of the QRS (QRS interval in ECG) complex over 120 msec or of the QTc-interval over 450 msec at the first screening visit
- Presence or history of arrhythmic disturbances; or known congenital QT (QT interval in ECG) prolongation
- Systolic blood pressure below 100 or above 140 mmHg
- Diastolic blood pressure below 50 or above 90 mmHg
- Heart rate below 50 or above 90 beats/ min
Key Trial Info
Start Date :
July 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04727021
Start Date
July 4 2017
End Date
October 27 2017
Last Update
January 27 2021
Active Locations (1)
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1
CRS Clinical-Research-Services Mönchengladbach GmbH
Mönchengladbach, North Rhine-Westphalia, Germany, 41061