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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT05463094
Eligibility Criteria:
Inclusion Criteria:
* Participants who are overtly healthy as determined by medical evaluation, including medical history, ECG recording and physical examination judged by investigator.
* Participants with a body weight within 50 to 90 kg (kilogram) and BMI (body mass index) within the range 19 to 26 kg/m2 (kilogram per meter square).
* Participants with all values for biochemistry and hematology tests of blood and urine within the normal range or showing no clinically relevant deviation as judged by the Investigator.
* Other protocol defined inclusion criteria could apply.
Exclusion Criteria:
* Participants with any surgical or medical condition, including findings in the medical history or in the pretrial assessments, or any other significant disease, that in the opinion of the Investigator, constitutes a risk or a contraindication for the participation in the study or that could interfere with the study objectives, conduct or evaluation.
* Participants with history or presence of relevant liver diseases or hepatic or renal dysfunction.
* Participants with history of surgery of the gastrointestinal tract which could influence the gastrointestinal absorption and/or motility according to the Investigator's opinion.
* Participation in a clinical study within 90 days prior to first drug administration.
* Non-acceptance of study high-fat breakfast.
* Other protocol defined exclusion criteria could apply .
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05463094
Study Brief:
Protocol Section:
NCT05463094