臨床研究等提出・公開システム

Date of registration	Jan. 17, 2025
Last modified on	June. 29, 2026
Trial ID	jRCT2031240538

Scientific Title	Pharmacokinetic study of HP-6050 - Investigation of application site -
Public Title	Pharmacokinetic study of HP-6050 - Investigation of application site -

Contact for Scientific Queries	Name	Inakura Hiroshi
	Affiliation	Hisamitsu Pharmaceutical Co., Inc.
	Address	2-4-1 Marunouchi, Chiyoda-ku, Tokyo
	Telephone	+81-3-5293-1734
	E-mail	shikenjoho@hisamitsu.co.jp
Contact for Public Queries	Name	Clinical Development Department Contact for Clinical Trial Information
	Affiliation	Hisamitsu Pharmaceutical Co., Inc.
	Address	2-4-1 Marunouchi, Chiyoda-ku, Tokyo
	Telephone	+81-3-5293-1734
	E-mail	shikenjoho@hisamitsu.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Jan. 31, 2025
Actual date of first enrollment		Jan. 27, 2025
Target sample size		15
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	crossover assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- Healthy Japanese elderly subjects aged >=65 years
	Exclusion Criteria	- Subjects with serious cardiovascular, renal, hepatic, neuropsychiatric, or metabolic disease, or with a history of these diseases - Subjects who received any drug within 1 week prior to the use of the investigational product - Subjects who took any drug considered to affect drug metabolism within 4 weeks prior to the use of the investigational product
	Age Minimum	65age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Patients with delirium, psychomotor agitation, or irritability
Intervention(s)		Application to site 1: A single dose of HP-6050 (Microneedle) will be applied to site 1. Application to site 2: A single dose of HP-6050 (Microneedle) will be applied to site 2. Application to site 3: A single dose of HP-6050 (Microneedle) will be applied to site 3. Application to site 4: A single dose of HP-6050 (Microneedle) will be applied to site 4. Application to site 5: A single dose of HP-6050 (Microneedle) will be applied to site 5.
Primary Outcome(s)		Pharmacokinetics, Safety, Pharmacodynamics

Primary Sponsor	Hisamitsu Pharmaceutical Co., Inc.

Secondary Sponsor

Name of Certified Review Board	Review Board of Human Rights and Ethics for Clinical Studies Institutional Review Board
Address	2-2-1, Kyobashi, Chuo-ku, Tokyo
Telephone	+81-3-6605-0572
E-Mail	soudan@hurecs.org
Approval Status	Approval
Date of approval	Jan. 20, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	June. 29, 2026	(this page)	Changes
3	Aug. 06, 2025	Detail	Changes
2	Feb. 07, 2025	Detail	Changes
1	Jan. 17, 2025	Detail

List of change history