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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT01739660
Eligibility Criteria:
Inclusion Criteria:
1. 18 and 75 years of age, inclusive
2. Agrees to employ best possible methods to abstain from becoming pregnant or impregnating another.
3. Stage V chronic kidney patients with minimal or no residual renal function receiving hemodialysis and stable on hemodialysis (3x week)
4. BMI = 18.5 kg/m2 to \< 45 kg/m2
Exclusion Criteria:
1. Any surgical or medical condition that may interfere with drug absorption, distribution, metabolism, or excretion, or any other condition that may place the subject at risk
1. Glucose-6-phosphate dehydrogenase (G6PD) deficiency
2. Uncontrolled congestive heart failure
3. Refractory chronic gout
2. History of drug and/or alcohol abuse within 6 months prior to screening
3. History of or current clinically significant mental disorder or an antagonistic personality that compromises the validity of the informed consent
4. Donation of blood or plasma within 30 days prior to dosing
5. History of or current hepatitis, or carriers of hepatitis B surface antigen (HbsAg) and/or hepatitis C antibodies (anti-HC).
6. Use of an investigational drug or product, within 30 days
7. History of clinically significant drug allergies or sensitivities
8. Females with a positive pregnancy test or who are breast feeding at Screening or plan to breast feed within 30 days of dosing
9. A baseline QTc interval ≥ 490 milliseconds for males and ≥ 510 milliseconds for females
10. Is unable to refrain from alcohol
11. Has taken any prescription or over the counter medication within 7 days prior to treatment day that, in the opinion of the Investigator, could be expected to confound the PK or metabolism of the study drug
12. Has taken the following herbal agents or nutraceuticals within 7 days prior to Screening: chapparal, comfrey, germander, gin bu huan, kava, pennyroyal, skullcap, St. John's Wort, or valerian
13. Has poorly controlled malignant hypertension (systolic blood pressure \[SBP\] \> 200 mm Hg and/or diastolic blood pressure \[DBP\] \> 120 mm Hg,
14. Concurrent use of urate-lowering drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01739660
Study Brief:
Protocol Section:
NCT01739660