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 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT02254057
Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
* Age \>= 18 and \<= 55 years
* BMI \>= 18.5 and \<= 29.9 kg/m2
Exclusion Criteria:
* Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* Relevant history of orthostatic hypotension, fainting spells or blackouts
* Any bleeding disorder including prolonged or habitual bleeding
* History of other hematologic disease, cerebral bleeding (e.g. after a car accident), commotio cerebri
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Seasonal rhinitis
* Thrombocytes \< 150000/μl
* Intake of drugs with a long half-life (\> 24 hours) (\< 1 month prior to administration or during the trial)
* Use of any drugs, which might influence the results of the trial (\< 10 days prior to administration or during the trial)
* Participation in another trial with an investigational drug (\< 2 months prior to administration or during trial)
* Smoker (\> 10 cigarettes or \>3 cigars or \>3 pipes/day)
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Use of methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.), grapefruit or grapefruit juice, alcohol, green tea, or tobacco \< 5 days prior to administration of study drug or during trial
* Blood donation or loss \> 400 ml, \< 1 month prior to administration or during the trial
* Excessive physical activities \< 5 days prior to administration of study drug or during trial
* Clinically relevant laboratory abnormalities
* Any ECG value outside of the reference range of clinical relevance including, but not limited to QRS interval \> 110 ms or QTcB \> 450 ms
* Inability to comply with dietary regimen of study centre
* Inability to comply with investigator's instructions
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02254057
Study Brief:
Protocol Section:
NCT02254057