臨床研究等提出・公開システム

Date of registration	Oct. 11, 2019
Last modified on	July. 02, 2021
Trial ID	jRCTs031190115

Scientific Title	Pharmacokinetics and pharmacodynamics study of coadministration of either allopurinol or febuxostat and inosine
Public Title	PK & PD of coadministration of XOR inhibitor and inosine

Completion date	May. 28, 2021
Result actual enrolment	0
Baseline Characteristics	None
Participant flow	None
Adverse events	None
Outcome measures	None
Brief summary	The study ended with 0 cases due to financial reasons.
Date of posting of results summaries	June. 30, 2021

Plan to share IPD	No
Plan description	None
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs031190115

Contact for Scientific Queries	Name	Kamatani Naoyuki
	Affiliation	Tsukuba International Clinical Pharmacology Clinic
	Address	21-16, Kan-nondai 1-chome, Tsukuba-shi, Ibaraki, Japan
	Telephone	+81-29-839-1150
	E-mail	kamatani@msb.biglobe.ne.jp
Contact for Public Queries	Name	Mochii Masa-aki
	Affiliation	Tsukuba International Clinical Pharmacology Clinic
	Address	21-16, Kan-nondai 1-chome, Tsukuba-shi, Ibaraki, Japan
	Telephone	+81-29-839-1150
	E-mail	m-mochii@tsukuba-icp.jp

Recruitment status	Complete

Anticipated date of first enrollment		Oct. 11, 2019
Target sample size		28
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	dose comparison control
	assignment	crossover assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion 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).
	Exclusion 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
	Age Minimum	20age old over
	Age Maximum	40age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Parkinson's disease
Intervention(s)		Coadministration of allopurinol and inosine, or coadministration of febuxostat and inosine
Health Condition(s) Keyword		neurodegenerative disease
Primary Outcome(s)		Concentration of hypoxanthine in blood
Secondary Outcome(s)		1. Cmax and AUC for febuxostat, allopurinol and oxypurinol 2. Serum urate 3. Blood ATP concentration 4. Concentration of xanthine in blood

Source of Monetary Support / Secondary Sponsor	StaGen Co. LTD
Secondary Sponsor	Not applicable

Name of Certified Review Board	National Institutes for Quantum and Radiological Science and Technology Certified Review Board
Address	Anagawa 4-9-1, Inage-ku, Chiba-shi, Chiba
Telephone	+81-43-206-4706
E-Mail	helsinki@qst.go.jp
Approval Status	Approval
Date of approval	Sept. 27, 2019

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	July. 02, 2021	(this page)	Changes
4	Sept. 29, 2020	Detail	Changes
3	May. 07, 2020	Detail	Changes
2	Jan. 07, 2020	Detail	Changes
1	Oct. 11, 2019	Detail

List of change history