臨床研究等提出・公開システム

Date of registration	Aug. 23, 2023
Last modified on	Mar. 28, 2024
Trial ID	jRCT2071230052

Scientific Title	Phase I study to investigate the pharmacokinetics, food effect, and safety of AKP-009 after single and multiple oral doses
Public Title	AKP-009 Phase I clinical trial

Contact for Scientific Queries	Name	Shimomiya Kazuhiro
	Affiliation	ASKA Pharmaceutical Co., Ltd.
	Address	2-5-1, Shibaura, Minato-ku, Tokyo, Japan
	Telephone	+81-70-4506-8531
	E-mail	aska-clinical@aska-pharma.co.jp
Contact for Public Queries	Name	Shimomiya Kazuhiro
	Affiliation	ASKA Pharmaceutical Co., Ltd.
	Address	2-5-1, Shibaura, Minato-ku, Tokyo, Japan
	Telephone	+81-70-4506-8531
	E-mail	aska-clinical@aska-pharma.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Sept. 19, 2023
Target sample size		81
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	- Individuals who are capable of understanding the nature of the study and can provide written voluntary consent to participate in the study - Healthy adult Japanese men 65 to 85 years of age (inclusive) at the time of informed consent for the multiple-dose 20 mg-H group, and healthy adult Japanese men 20 to 40 years of age (inclusive) at the time of informed consent for the other groups - Individuals with a BMI of >= 18.5 and <= 25.0 at screening
	Exclusion Criteria	- Individuals with current or previous disease considered inappropriate for participation in the study, such as liver disorders, kidney disorders, cerebrovascular/cardiovascular disorders, gastrointestinal disorders, blood diseases, or endocrine diseases - Individuals with drug allergy - Individuals with current or previous convulsive disorder such as epilepsy - Individuals with current or previous alcoholism - Individuals who test positive for drug abuse at screening - Individuals who test positive for HBs antigen, HCV antibody, HIV antigen/antibody, or serological syphilis at screening - Individuals who weigh less than 50 kg at screening - Individuals from whom at least 200 mL or 400 mL of blood had been collected within 4 or 12 weeks before study treatment, respectively, or who had donated blood component within 2 weeks before study treatment - Individuals who are considered by the investigator/subinvestigator to be unsuitable for participation in the study based on the medication status within 1 week before study treatment - Individuals who had participated in another clinical trial within 16 weeks before study treatment
	Age Minimum	20age old over
	Age Maximum	85age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Benign prostatic hyperplasia
Intervention(s)		Single-dose groups: single oral dose of AKP-009 (5 mg, 10 mg, 20 mg, 40 mg, 80 mg, 160 mg or 240 mg) or placebo Multiple-dose groups: multiple oral doses of AKP-009 (5 mg, 10 mg, 20 mg or 40 mg) or placebo once daily for 10 days
Primary Outcome(s)		Pharmacokinetics and safety

Primary Sponsor	ASKA Pharmaceutical Co., Ltd.

Name of Certified Review Board	Hakata Clinic Institutional Review Board
Address	6-18 Tenyamachi, Hakata-ku, Fukuoka-shi, Fukuoka
Telephone	+81-92-283-7701
E-Mail	miyako-koga@lta-med.com
Approval Status	Approval
Date of approval	Aug. 31, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Mar. 28, 2024	(this page)	Changes
1	Aug. 23, 2023	Detail

List of change history