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 @ 12:10 PM
Ignite Modification Date:
2025-12-24 @ 12:10 PM
NCT ID:
NCT02317861
Eligibility Criteria:
Inclusion Criteria:
* Screening serum uric acid level ≥ 8 mg/dL;
* Body weight ≥ 50 kg and a body mass index (BMI) ≥ 18 and ≤ 40 kg/m2;
* Free of any clinically significant disease or medical condition, per the Investigator's judgment.
Exclusion Criteria:
* History or suspicion of kidney stones;
* Diagnosis of benign prostatic hypertrophy (BPH) or neurogenic bladder or evidence of BPH/neurogenic bladder such as thin urinary stream or difficulty in urination;
* An estimated creatinine clearance \< 60 mL/min calculated by the Cockcroft-Gault formula;
* QTcF interval (QT interval corrected for heart rate using Fridericia's formula) \> 450 msec at Screening;
* Receiving strong or moderate Cytochrome P450 (CYP) 3A inhibitors or p-glycoprotein inhibitors, or digoxin
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT02317861
Study Brief:
Protocol Section:
NCT02317861