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 @ 10:02 PM
Ignite Modification Date:
2025-12-24 @ 10:02 PM
NCT ID:
NCT05963932
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female participants without clinically significant deviation from normal, as determined by the investigator, in medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations.
* Body mass index (BMI) of 18.0 to 32.0 kilograms per meter squared (kg/m\^2), inclusive, and body weight ≥ 50 kg.
* A female participant is eligible to participate if she is a woman not of childbearing potential (WNOCBP)
Exclusion Criteria:
* Any significant acute or chronic medical illness (eg, history of intracranial or intraspinal hemorrhage, CNS lesions, recent bacterial or fungal meningitis, etcetera) as determined by the investigator.
* Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could affect the absorption, distribution, metabolism, and excretion of study intervention (for example, bariatric procedure).
* History of Gilbert's syndrome.
* Women who are of childbearing potential and women who are breastfeeding.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05963932
Study Brief:
Protocol Section:
NCT05963932