PK & PD of coadministration of XOR inhibitor and inosine

JRCT ID: jRCTs031190115

Registered date:11/10/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Parkinson's disease
• Date of first enrollment: 11/10/2019
• Target sample size: 28
• Study type: Interventional
• Intervention(s): Coadministration of allopurinol and inosine, or coadministration of febuxostat and inosine

Outcome(s)

• Primary Outcome: Concentration of hypoxanthine in blood

Secondary Outcome

1. Cmax and AUC for febuxostat, allopurinol and oxypurinol
2. Serum urate
3. Blood ATP concentration
4. Concentration of xanthine in blood

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 40age old
• Gender: Male

Include criteria

1) Japanese healthy adult male
2) A person who voluntarily applied to the study and is determined by the principal investigator or subinvestigators to understand the contents of the explanatory document.
3) A person who has received sufficient explanation about the purpose and content of this study, has the ability to consent, fully understands and agrees to participate by writing, in a voluntary manner, in the document.
4) Age 20 to 40 (age is on the date of consent)
5) Person with a BMI of 17.6 or more and less than 26.5 (BMI is at the time of screening test).

Exclude criteria

1) Regular users of pharmaceuticals or supplements
2) Persons who are being treated for disease
3) Persons with renal impairment or past history of the renal impairment
4) History of gout, hyperuricemia or urolithiasis
5) History or present illness of renal disorder
6) History or present illness of cardiovascular disorder
7) Persons with hypersensitivity to drugs, idiosyncrasies (allergies), or past history of those
8) Those who have a disease or disorder in the heart, kidney, respiratory system, digestive system, blood function, etc. that may affect the absorption, distribution, metabolism, or excretion of the drug
9) Those who have participated in other clinical trials such as clinical trials of drugs containing new active ingredients within the past 4 weeks from the start date of test drug administration
10) Those who donated 400mL blood within the past 12 weeks, 200mL blood within 4 weeks, or blood component within 2 weeks from the screening test date
11) Other persons who are judged to be ineligible by the principal investigator or subinvestigator

Related Information

• Primary Sponsor: Kamatani Naoyuki
• Source(s) of Monetary Support: StaGen Co. LTD