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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT02151994
Eligibility Criteria:
Inclusion Criteria:
Subjects were eligible for the study if they met all the following inclusion criteria:
* Gender - male
* Age - 18 - 55 years, inclusive
* Body Mass Index (BMI) - 18.0 - 30.0 kg m2 (BMI (kg m2) = Body weight (kg) - Heigh t2 (m 2))
* Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, power drinks), grapefruit (juice) and tobacco products from 48 h prior to entry in the clinical research centre until discharge
* Medical history without major pathology
* Normal resting supine blood pressure and pulse rate showing no clinically relevant deviations as judged by the MI
* Computerised (12-lead) ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the MI
* All values for haematology and for clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the MI
* Willingness to sign the written ICF
Exclusion Criteria:
Subjects were excluded from participation if any of the following exclusion criteria applied
* Any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, haematological, neurologic, or psychiatric disease
* An automatic ECG QTc interval reading at screening or enrolment of + 440 ms.
* Evidence of clinically relevant pathology
* Mental handicap
* History of relevant drug and or food allergies
* Smoking more than 10 cigarettes and or cigars and or pipes daily
* History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
* Use of any prescription drug within 30 days before study drug administration with the exception of influenza vaccination
* Use of any over-the-counter drugs including health supplements, herbal supplements such as St. John's Wort extract (except for the occasional use of acetaminophen (paracetamol), aspirin and vitamins - 100 recommended daily allowance) within 7 days before study drug administration. The use of paracetamol and or topical medication was allowed up to 3 days before entrance into the clinical research facility
* Participation in a drug study within 90 days prior to drug administration
* Participation in more than 3 other drug studies in the 10 months preceding the start of this study (this was the first administration of study drug)
* Donation of more than 50 mL of blood within 90 days prior to first drug administration
* Donation of more than 1.5 litres of blood in the 10 months preceding the start of this study (this was the first administration of study drug)
* Positive screen on drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids), barbiturates, benzodiazepines, tricyclic antidepressants and alcohol
* Intake of more than 24 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
* Positive screen on hepatitis B surface antigen (HBsAg)
* Positive screen on anti hepatitis C virus (HCV)
* Positive screen on anti human immunodeficiency virus (HIV) 1 - 2
* Acute disease state indicated as clinically relevant by the MI (e.g. nausea, vomiting, fever, diarrhoea) within 7 days before the first drug administration
* Non-willingness to consume the Food and Drug Administration (FDA) breakfast (FE part only)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02151994
Study Brief:
Protocol Section:
NCT02151994