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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT02538393
Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects between the ages of 18 (inclusive) and 45 years (inclusive) at the first screening visit.
* Body mass index (BMI) between 18.0 (inclusive) and 32.0 kg / m² (inclusive).
* Non-smoker or former smoker who has stopped smoking at least 3 months before the first study drug administration
* Ability to understand and follow study-related instructions
* Any subject who is a sexually active man and has not been surgically sterilized must consent to use a condom during intercourse and ensure that his female partner practices adequate contraception, or he must be willing to refrain from sexual intercourse from the beginning of the trial until 30 days after last study drug administration.
Exclusion Criteria:
* Medical and surgical history:
* Failure of a major organ system or a medical disorder that would impair the subject's ability to complete the study or that would alter the absorption and pharmacokinetics of the study drug
* Active infections or other medical, psychological or social problems of sufficient severity to limit full compliance with the trial
* Known severe allergies, non-allergic drug reactions, or multiple drug allergies
* History of clinically significant metabolic, renal, hepatic, or cardiovascular disease or central nervous system disorder
* Clinically significant illness within 30 days before first study drug administration.
* Febrile illness within 1 week before the first study drug administration
* Known hypersensitivity to study drug
* Incompletely cured 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
* Electrocardiogram (ECG), blood pressure, heart rate:
* Clinically relevant findings in the ECG (e.g. a second- or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QTc-interval over 450 msec)
* Laboratory examination:
* Clinically relevant deviations of the screened laboratory parameters from reference ranges (especially for gamma-GT, ALT, AST, or bilirubin)
* Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02538393
Study Brief:
Protocol Section:
NCT02538393