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:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-25 @ 3:13 AM
NCT ID:
NCT02209805
Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with Good Clinical Practice and local legislation
* Age \>= 18 and \<= 45 years
* Broca \>= - 20 % and \<= + 20%
* Able to communicate well with the investigator and to comply with study requirements
* \> 10 elimination half lives present since last use of any investigational drug for that investigational drug
* Laboratory values within a clinically relevant reference range
Exclusion Criteria:
* Any finding of the medical examination (including blood pressure, pulse rate, temperature, and EKG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* History of vasculitis (past history of fever, malaise, myalgias, rash, etc.)
* 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 (\< 1 months prior to administration or during trial)
* Smoker
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Use of methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.) \< one week prior to administration of study drug
* Blood donation or loss \> 400 mL (\< 1 month prior to administration or during the trial)
* Excessive physical activities (\< 5 days prior to administration or during the trial)
* Following specific laboratory findings: total white blood cell \>= 10 x 109/L, C-Reactive Protein \>= 4.5 mg/L, gamma-glutamyl-transferase \>= 25 U/L, aspartate transaminase \>= 16 U/L, alanine transaminase \>= 20 U/L any erythrocytes or \> 15 mg/dl protein on urine dipstick
* Any EKG value outside of the reference range of clinical relevance including, but not limited to QTcB \> 480 ms, PR interval \> 240 ms, QRS interval \> 110 ms
* History of any familial bleeding disorder
* 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:
45 Years
Study:
NCT02209805
Study Brief:
Protocol Section:
NCT02209805