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 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT04489134
Eligibility Criteria:
Inclusion Criteria:
* adults (\> 18 years)
* Non smokers (for at least 6 months)
* Biological parameters within normal range (blood count, urea, creatinine, AST, ALT, GGT, bilirubine)
* BMI within 18 and 25
* Vaccinated against Covid 19
* Negative urinary and plasma pregnancy test
* Having effective contraception for the duration of the study and for 10 days after the last administration of the study treatment (for women and men of childbearing potential)
* Informed consent
Exclusion Criteria:
* participation to another study with incompatible procedure regarding the French law on research
* Treatment with a drug drug interaction with tacrolimus
* Cardiac rhythm at rest below 50 bpm
* Cardiac issue detected on electrocardiogram
* Cancer or history of cancer
* Chronic infection or history of chronic infection
* Diabetes or history of diabetes
* Hypertension or history of hypertension
* Pregnancy or lactation
* Deprived of liberty (curatorship, guardianship or incarcerate)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04489134
Study Brief:
Protocol Section:
NCT04489134