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 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT05267769
Eligibility Criteria:
Inclusion Criteria:
1. Signed and dated informed consent form
2. Male at the age of 30 - 60 years at study start
3. Body mass index of 18 to 30 kg/m2
4. Non-smoker, no use of any tobacco products,
5. Good general health status (Karnofsky Score = 100; see Annex 1, page 59)
6. Current ECG without abnormal findings (no significant alterations from normal values, especially with regard to the QT interval (QTcF \< 450 ms)
7. Physical examination, medical history without exclusionary findings
8. Pulse rate between 50 and 90 bpm
9. Blood pressure between systolic 90 - 140 mmHg, diastolic 50 - 90 mmHg
10. Lab values for liver function (ALT, AST, AP, Bilirubin total) within normal ranges
11. Lab value for renal function (S-Creatinine, eGFR according to CKD-EPI) within normal range
12. Negative test result on HIV I, HIV II, hepatitis B cell surface antigen, hepatitis C antibody
13. Negative test result of urine screening for Cannabis and substance abuse
Exclusion Criteria:
1. Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
2. Use of Cannabis products within the last 8 weeks
3. Use of opioids
4. Former or present dependency (e.g. to alcohol, medicinal products, drugs)
5. Participation in another clinical trial within the last four weeks prior to study inclusion
6. Former or present mental illnesses such as severe depression, psychosis, bipolar disorder, mania, obsessive compulsive disorder, and anxiety disorder
7. Acute severe somatic disease (e.g. gastrointestinal diseases, influenza)
8. Body temperature ≥ 38°C
9. Present cardiovascular, respiratory, diabetic, or cancer disease
10. Hepatitis A, B, C or other liver and renal disease
11. Other diseases or conditions that do not allow the participant to assess the nature and scope, and possible consequences of participating in this clinical trial
12. Indications that the participant is unlikely to comply with the study protocol (e.g. lack of cooperation)
13. Taking any pharmaceutical products (including any medication interacting with metabolism of THC, e.g. St. John's wort)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
30 Years
Maximum Age:
60 Years
Study:
NCT05267769
Study Brief:
Protocol Section:
NCT05267769