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 @ 2:25 PM
Ignite Modification Date:
2025-12-24 @ 2:25 PM
NCT ID:
NCT03471559
Eligibility Criteria:
Inclusion Criteria:
* Informed consent given by the subject
* Negative drug screening at the time of screening
* Non-smoking
* In female participants in fertile age, reliable contraception, which means contraception's Pearl index is equal to or smaller than 1.
* Body Mass Index between 18.5 kg/m2 and 30 kg/m2
Exclusion Criteria:
* Lack of accountability
* Pregnancy or lactation phase in females at the time of screening
* Any known psychiatric or neurological illness in the participant's history.
* Known family history regarding psychiatric disorders with an increased lifetime risk for psychiatric disorders in the participant (investigators qualified judgement)
* Relevant use of cannabis (which is defined on the present state of knowledge as more than five times lifetime consumption and/or more than two consumptions during the last year)
* Consumption of any illicit drugs (except cannabis in history, see above)
* Severe physical (internal) or neurological illness, especially cardiovascular, renal, advanced respiratory, haematologic or endocrinologic disorders or infectious diseases (acute hepatitis A, B or C or HIV) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, as assessed by the investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03471559
Study Brief:
Protocol Section:
NCT03471559