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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT03651466
Eligibility Criteria:
Inclusion Criteria:
1. male subjects aged between 18-50 years (both inclusive)
2. healthy subjects as determined by medical history, physical examination including vital signs, ECG and clinical laboratory testing
3. subjects who are able and willing to give written informed consent
4. male subjects must be using 2 acceptable methods for contraception (one of these methods should be a barrier method e.g. spermicide and condom) from start of dosing and refrain from fathering a child in the 3 months following dosing.
Exclusion Criteria:
History of:
1. clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing), especially allergy to macrolide antibiotics;
2. any clinically significant pancreatic, hepatic, renal, gastrointestinal, cardiovascular, respiratory, hematological, central nervous system diseases or other significant diseases which might influence either the safety of the subject or the absorption, metabolism or excretion of the active agent under investigation;
3. diabetes mellitus and thyroid dysfunction or other endocrine disorders;
4. malignancy;
5. substance abuse or addiction (alcohol, drugs) in the past 3 years.
Present Condition:
6. participation in a clinical investigation within the 30 days prior to the planned first drug administration or during this trial;
7. participation in this study at a previous dose level;
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03651466
Study Brief:
Protocol Section:
NCT03651466