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 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
NCT ID:
NCT07121959
Eligibility Criteria:
The main inclusion criteria include, but are not limited to:
* Is a continuous non-smoker for at least 3 months prior to dosing
* Has body mass index (BMI) ≥ 18.0 and ≤ 42.0 kg/m2
* Is able to swallow multiple tablets
The main exclusion criteria include, but are not limited to:
* Has a history of cancer (malignancy)
* Has a history of anemia within the last 5 years
* Has a known history or presence of metabolic acidosis, ketoacidosis, or lactic acidosis
* Has a hemoglobin level below the lower limit of normal
* Has a pulse oximetry reading less than 92% at rest
* Is known to be a cytochrome P450 (CYP2C19) poor metabolizer or likely poor metabolizer based on genotyping prior to the screening visit or is determined to be a CYP2C19 poor metabolizer
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07121959
Study Brief:
Protocol Section:
NCT07121959