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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT04281758
Eligibility Criteria:
Inclusion Criteria:
1. Healthy adult male volunteers aged 18 to 55 years.
2. Have a BMI of 18 to 29 kg/m2 (inclusive)
3. Able to comprehend and willing to sign an Informed Consent Form (ICF).
4. Willing to avoid caffeine for ≥48 hrs prior to visits
5. Willing to avoid alcohol for ≥24 hrs prior to visits
6. Willing to fast 10 hrs prior to visits
7. Willing to stick to their usual dietary patterns
8. Willing to stick to their usual physical activity level throughout the study
9. No participation in any clinical trial within the past 30 days or any PEP protocol within the past 6 months.
Exclusion Criteria:
1. Reported history or clinical manifestations of significant metabolic (including type 1 or type 2 diabetes mellitus), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders.
2. Current or recent history (\<30 days prior to Screening) of a clinically significant bacterial, fungal, or mycobacterial infection
3. Current clinically significant viral infection
4. History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin
5. Resting heart rate less than 45 bpm or greater than 100 bpm.
6. History of unstable ischemic heart disease or uncontrolled hypertension (blood pressure greater than or equal to 150/90 mm Hg)
7. History of stomach or intestinal surgery, except that appendectomy and/or cholecystectomy will be allowed.
8. Presence of a malabsorption syndrome possibly affecting drug/Product absorption (e.g., Crohn's disease or chronic pancreatitis).
9. Extreme dietary habits, including but not limited to vegetarian diets and intentional consumption of a high fiber diet, gluten-free, low-carb, vegan, ketogenic.
10. History of alcoholism or drug addiction within 1 year prior to Screening, or current alcohol or drug use that, in the opinion of the investigator, will interfere with the subject's ability to comply with the dosing schedule and study evaluations.
11. Use of any tobacco-containing or nicotine-containing products (including cigarette, pipe, cigar, chewing tobacco, nicotine patch, or nicotine gum and vaping products) within 2 months prior to study entry.
12. Use of any prescription or nonprescription drugs (including vitamins, minerals, and phytotherapeutic, herbal, or plant-derived preparations) is prohibited within 7 days prior to the dose of study product, unless deemed acceptable by the Investigator.
13. Use of alcohol-containing within 24 hours prior to study entry.
14. Use of caffeine containing products 48 hours prior to each dose of study product and during each dosing day.
15. Donation of blood in excess of 500 ml within 4 weeks prior to study entry or of plasma within 2 weeks prior to Screening.
16. Receipt of blood products within 3 months prior to study entry.
17. Subjects who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04281758
Study Brief:
Protocol Section:
NCT04281758