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 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT05518734
Eligibility Criteria:
Key Inclusion Criteria:
* Male and female of non-childbearing potential are eligible
* Body mass index (BMI) of 18.0 to 32.0 kilograms per meter square (kg/m\^2)
* A total body weight greater than (\>) 50 kg
Key Exclusion Criteria:
* History of febrile illness or other acute illness within 14 days before the first dose of study drug
* History of cardiac dysrhythmias
* Part A Cohorts with Midazolam DDI Evaluation (Cohort A4) Only
* Hypersensitivity to midazolam or benzodiazepines
* Part A Cohorts with CSF Sampling (Cohorts A2 and A3) Only
* Hypersensitivity to local anesthetic for lumbar puncture
* History of conditions leading to increased intracranial pressure (e.g., brain tumor, idiopathic intracranial hypertension, venous sinus thrombosis)
* Part B Only
* Hypersensitivity to itraconazole
Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05518734
Study Brief:
Protocol Section:
NCT05518734