Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-24 @ 3:20 PM
NCT ID:
NCT04720092
Eligibility Criteria:
Inclusion Criteria:
* The informed consent had to be signed before any study specific tests or procedures were done
* Healthy male subjects
* Age: 18 to 55 years (inclusive) at the screening examination/visit
* Race: White
* Body mass index (BMI): above/equal 18 and below/equal 29.9 kg/m\^2
* Ability to understand and follow instructions
Exclusion Criteria:
* 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
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04720092
Study Brief:
Protocol Section:
NCT04720092