A Food-Drug Interaction Study of Serum Urate After Oral Inosine

Eighteen (18) eligible healthy male subjects will be randomly assigned to two groups with 9 subjects per group to receive a single oral dose of 1000 mg inosine with or without food on day 1 after an overnight fast. Subjects who receive inosine with food on day 1 will receive a second dose of inosine without food on day 8 after an overnight fast. Subjects who receive inosine without food on day 1 after an overnight fast will receive a second dose of inosine with food on day 8 after an overnight fast.

Subjects will be admitted to the clinic before dinner on days 0 and 7, the days before dosing, and will stay in the clinic for 48-h post-dose. During the clinic stay, blood samples will be taken for urate measurements.

Inclusion criteria

• Healthy male subjects between the ages of 18 and 65 years
• Body-mass index between 18.0 kg/m2 and 32.0 kg/m2
• 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
• Serum urate < 6.1 mg/dL (approximately 360 μM) at screening
• Non-smokers for at least 6 months prior to screening
• Adequate venous access at multiple sites in both arms

Exclusion criteria

• History of alcohol or drug dependence in the past 2 years
• 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
• Used prescription or over-the-counter (OTC) drugs within 14 days prior to screening
• Used vitamin preparations or supplements (including St. John's Wort and ginseng) within 28 days prior to the screening test
• 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
• 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
• 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
• Known HIV disease
• Had a febrile illness within 5 days prior to the first dose of study medication
• Vaccinated within 30 days prior to the first dose of medication
• Has gout or a history or suspicion of kidney stones
• Determined by the investigator or sub-investigator to be unsuitable for participating in the study based on medical conditions