臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 16, 2022
Last modified on	July. 13, 2023
Trial ID	jRCT2071220057

Scientific Title	A phase I open-label study to investigate the absorption, metabolism and excretion of [14C]KDT-3594 following single oral administration in healthy adult male subjects
Public Title	A mass-balance study of [14C]KDT-3594 in healthy adult male

Contact for Scientific Queries	Name	Shimizu Yoshitaka
	Affiliation	Kissei Pharmaceutical Co., Ltd.
	Address	3-1-3, Koishikawa, Bunkyo-Ku, Tokyo, 112 0002, Japan
	Telephone	+81-120-007-622
	E-mail	rinsyousiken@pharm.kissei.co.jp
Contact for Public Queries	Name	Shimizu Yoshitaka
	Affiliation	Kissei Pharmaceutical Co., Ltd.
	Address	3-1-3, Koishikawa, Bunkyo-Ku, Tokyo, 112 0002, Japan
	Telephone	+81-120-007-622
	E-mail	rinsyousiken@pharm.kissei.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Oct. 01, 2022
Actual date of first enrollment		Nov. 08, 2022
Target sample size		8
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- Healthy Japanese male - Age: >18 to =<45 years old - BMI: >=18.5 to <25.0 kg/m2 - Body weight: >=50 kg
	Exclusion Criteria	Subjects with complication or history of clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, (including alcoholic liver disease, non-alcoholic steatohepatitis (NASH), autoimmune hepatitis, and hereditary liver disease), psychiatric, neurological, or allergic disease (including drug allergy, but excluding untreated, asymptomatic or seasonal allergy at the time of administration)
	Age Minimum	18age old over
	Age Maximum	45age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Healthy condition
Intervention(s)		Single oral administration of 50 mL of [14C]KDT-3594 solution (equivalent to 0.4 mg as KDT-3594, approximately 0.75 MBq as administered radioactivity) under fasted conditions
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Urinary and fecal radioactivity excretion and excretion rate, cumulative excretion and cumulative excretion rate, recovery and recovery rate, total recovery and total recovery rate
Secondary Outcome(s)		- Radioactivity concentration in whole blood and plasma - Concentration of unchanged drug and main metabolites in plasma - Metabolite profiling and structural estimation of metabolites in plasma, urine and feces - Incidence of adverse events and adverse drug reactions - Laboratory tests, vital signs, body weight, 12-lead ECG

Primary Sponsor	Kissei Pharmaceutical Co., Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Hakata Clinic Institutional Review Board
Address	6-18, Tenyamachi, Hakata-ku, Fukuoka city, Fukuoka 812 0025, Japan, Fukuoka
Telephone	+81-92-283-7701
E-Mail
Approval Status	Approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	July. 13, 2023	(this page)	Changes
2	Feb. 12, 2023	Detail	Changes
1	Oct. 16, 2022	Detail

List of change history