臨床研究等提出・公開システム

Date of registration	Jan. 22, 2021
Last modified on	April. 01, 2026
Trial ID	jRCT2051200119

Scientific Title	Clinical Pharmacology Study of AK1830 (Drug-Drug Interaction Study in Healthy Men)
Public Title	Clinical Pharmacology Study of AK1830 (Drug-Drug Interaction Study in Healthy Men)

Contact for Scientific Queries	Name	Shimizu Tomohito
	Affiliation	ASAHI KASEI THERAPEUTICS CORPORATION
	Address	1-1-2 Yurakucho, Chiyoda-ku, Tokyo
	Telephone	+81-3-6699-3600
	E-mail	ct-info@om.asahi-kasei.co.jp
Contact for Public Queries	Name	Contact for Clinical Trial Information
	Affiliation	ASAHI KASEI THERAPEUTICS CORPORATION
	Address	1-1-2 Yurakucho, Chiyoda-ku, Tokyo
	Telephone	+81-366993600
	E-mail	ct-info@om.asahi-kasei.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Feb. 07, 2021
Actual date of first enrollment		Feb. 07, 2021
Target sample size		20
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	The subjects will be individuals who meet all of the following criteria. [1] Healthy men [2] Individuals >=20 to <45 years of age at the time of informed consent [3] Individuals who fully understand the details of the study and who are capable of providing written informed consent
	Exclusion Criteria	Individuals meeting any of the following criteria will be excluded from the study. [1] Past history of disease of kidney, liver, heart, brain, or other conditions considered unsuitable for this study [2] Past history of disease or surgery that could affect absorption of the investigational product or designated concomitant drug [3] Other protocol defined exclusion criteria could apply
	Age Minimum	20age old over
	Age Maximum	44age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		healthy subjects
Intervention(s)		AK1830 oral administration and blood collection
Primary Outcome(s)		Plasma concentration of compound(s)

Primary Sponsor	ASAHI KASEI THERAPEUTICS CORPORATION

Name of Certified Review Board	Medical Corporation Heishinkai OPHAC Hospital IRB
Address	4-1-29, Miyahara, Yodogawa-ku, Osaka, Osaka
Telephone	+81-6-6395-9000
E-Mail	sumiko.kawamoto@heishinkai.com
Approval Status	Approval
Date of approval	Jan. 14, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	April. 01, 2026	(this page)	Changes
5	Mar. 10, 2022	Detail	Changes
4	Mar. 02, 2021	Detail	Changes
3	Feb. 15, 2021	Detail	Changes
2	Feb. 02, 2021	Detail	Changes
1	Jan. 22, 2021	Detail

List of change history