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 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT06106334
Eligibility Criteria:
Key Inclusion Criteria:
* Participants who are considered to be medically healthy as determined by the investigator
* Participants whose body mass index (BMI) is within the range of ≥ 18.5 to ≤ 30.0 kg/m\^2
* Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
* Participants who understand the study procedures and agree to participate by providing written informed consent
* Participants who are willing and able to comply with all study procedures and restrictions
Key Exclusion Criteria:
* Participants who have a history of clinically significant hypersensitivity or severe side effects induced by a drug.
* Participants who have a history of ventricular dysfunction, congestive heart failure, or pulmonary edema.
* Participants who have a history of gastrointestinal surgery including, but not limited to, cholecystectomy, gastric resection, and/or intestinal resection that may result in a clinically significant abnormality in gastrointestinal function (except for an appendectomy). Participants can be considered by the investigator (or sub-investigator) to be ineligible for the study due to a history of or current condition of significant metabolic or endocrine, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, immunological, neurological, or psychiatric disorders with clinical manifestations.
* Participants who are considered inappropriate for participation in the study for any reason by the investigator (or sub-investigator).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06106334
Study Brief:
Protocol Section:
NCT06106334