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:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
NCT ID:
NCT03092206
Eligibility Criteria:
Inclusion Criteria:
* Male, healthy volunteers, age range ≥18-40 years
* Written informed consent and willingness to attend study visits
* Willingness for taking study medication during study period
* Birth control during study period
Exclusion Criteria:
* Participation in other interventional clinical trials and/or participation in another clinical trial with medicinal products within the last 4 weeks
* Known allergies or contraindications against study medication
* Known metabolic dysfunction, e.g. Hypertriglyceridemia or Diabetes mellitus
* Smoking or alcohol abuse (\> 15g/day alcohol consumption)
* Documented HIV-infection
* BMI \<18 \>25
* Recurrent medication or any antiretroviral medication within the last 30 days
* ALT, AST, Bilirubin, Creatinine, TSH, blood pressure, heart rate, QTc are out of normal range
o Normal ranges for clinical chemistry are defined by local laboratory. For blood pressure normal range is defined as 100/60-140/90; for heart rate 60-100
* Known liver, kidney, heart, pulmonary, gastrointestinal, endocrinological, rheumathoid, neurological, psychiatric or metabolic diseases
* Any situation of which the sponsors sees relevant contraindication against study participation
* Imprisoned or situated people
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT03092206
Study Brief:
Protocol Section:
NCT03092206