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 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT02614469
Eligibility Criteria:
Inclusion Criteria:
1. Healthy male subjects between the ages of 18 and 65 years
2. Body-mass index between 18.0 kg/m2 and 32.0 kg/m2
3. If not surgically sterile, willing to refrain from donating sperm and willing to use appropriate birth control when engaging in sexual intercourse for a period of 90 days following the last dose of the study medication
4. Serum urate \< 6.1 mg/dL (approximately 360 μM) at screening
5. Non-smokers for at least 6 months prior to screening
6. Adequate venous access at multiple sites in both arms
Exclusion Criteria:
1. History of alcohol or drug dependence in the past 2 years
2. Had 400 mL of whole blood collection within four months or 200 mL of whole blood collection or who had blood component collection within one month of the screening test
3. Used prescription or over-the-counter (OTC) drugs within 14 days prior to screening
4. Used vitamin preparations or supplements (including St. John's Wort and ginseng) within 28 days prior to the screening test
5. Not willing to refrain from alcohol, grapefruit, grapefruit juice or related products, caffeine consumption (including chocolate), and strenuous exercise within 72 h prior to day 1 and through the end of the PK study
6. Treated with an investigational drug within 30 days or 7 half-lives of the investigational drug, whichever is longer, prior to the first dose of study drug
7. Previously received inosine supplement within three months from the screening or subjects who have had any inosine and suffered an adverse reaction due to it
8. Known HIV disease
9. Had a febrile illness within 5 days prior to the first dose of study medication
10. Vaccinated within 30 days prior to the first dose of medication
11. Has gout or a history or suspicion of kidney stones
12. Determined by the investigator or sub-investigator to be unsuitable for participating in the study based on medical conditions
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02614469
Study Brief:
Protocol Section:
NCT02614469