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 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT04906005
Eligibility Criteria:
Inclusion Criteria:
* A Japanese healthy volunteer is defined as being born in Japan and having both parents and four grandparents (maternal and paternal) who are ethnically Japanese and having Japanese lifestyle, including diet, as determined by participant's verbal report.
* Good health status as determined by investigator according to past medical history, clinical examination, including 12 lead ECG, vital signs (blood pressure, pulse rate, respiratory rate and body temperature) and laboratory tests at screening and inclusion.
Exclusion Criteria:
* Pregnant or breast-feeding female volunteer.
* Having acute or chronic renal insufficiency, defined as an eGFR (estimated Glomerular Filtration Rate) \<90mL/min/1.73 m2, calculated by using the Japanese coefficient-modified CKD-EPI formula.
* With known contra-indication(s) to the use or with known sensitivity to one of the products under investigation or to drugs from a similar pharmaceutical class.
* With known history of severe allergic or anaphylactic reactions to any allergen including drugs and contrast agents.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
59 Years
Study:
NCT04906005
Study Brief:
Protocol Section:
NCT04906005