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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT02336594
Eligibility Criteria:
Inclusion Criteria:
* Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study-related activity
* Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2
* Subject has a Screening serum urate level ≤ 7 mg/dL
* Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment
Exclusion Criteria:
* Subject has a history or suspicion of kidney stones
* Subject has undergone major surgery within 3 months prior to Screening
* Subject donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to Day 1
* Subject has inadequate venous access or unsuitable veins for repeated venipuncture
* Subject has a Screening serum creatinine value above the upper limit of normal during Screening or at Day -2 (Admission)
* Subject cannot swallow multiple tablets
* Subject is a heavy caffeine drinker
* Subject is unwilling to comply with the dietary restrictions of the study
* Subject is unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02336594
Study Brief:
Protocol Section:
NCT02336594