臨床研究等提出・公開システム

Japanese

Date of registration	Feb. 17, 2026
Last modified on	Feb. 17, 2026
Trial ID	jRCT2071250132

Scientific Title	A Randomized , Double-Blind, Placebo-Controlled Trial to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of TAK-495 in Healthy Participants
Public Title	A Study of TAK-495 in Healthy Adults

Contact for Scientific Queries	Name	Nonomura Hidenori
	Affiliation	Takeda Pharmaceutical Company Limited
	Address	1-1, Doshomachi 4-chome, Chuo-ku, Osaka
	Telephone	+81-6-6204-2111
	E-mail	smb.Japanclinicalstudydisclosure@takeda.com
Contact for Public Queries	Name	Contact for Clinical Trial Information
	Affiliation	Takeda Pharmaceutical Company Limited
	Address	1-1, Doshomachi 4-chome, Chuo-ku, Osaka
	Telephone	+81-6-6204-2111
	E-mail	smb.Japanclinicalstudydisclosure@takeda.com

Recruitment status	Pending

Anticipated date of first enrollment		Feb. 17, 2026
Target sample size		126
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. The participant must have no history of hypertension or use of antihypertensive medication. Blood pressure (BP) must be <140 mmHg (systolic) and <90 mmHg (diastolic) at screening and at Day -1. 2. The participant must be a current nonsmoker who has not used tobacco- or nicotine-containing products for at least 3 months before the first dose of trial intervention or first trial assessment.
	Exclusion Criteria	1. The participant has a history of cancer in past 10 years 2. The participant has a history of significant multiple and/or severe allergies, has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food, or has a known hypersensitivity to any component of the formulation of TAK-495 or related compounds.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Healthy Participants
Intervention(s)		Healthy adult participants will receive single and/or multiple oral doses of TAK-495.
Primary Outcome(s)		1. Number of Participants With At Least 1 TEAE Postdose Timeframe: 69 Days as a maximum TEAE: treatment-emergent adverse event.
Secondary Outcome(s)		1. PK of TAK-495 Following Single/Multiple Oral Doses in Healthy Adults

Primary Sponsor	Takeda Pharmaceutical Company Limited

Secondary Sponsor

Name of Certified Review Board	Hakata Clinic IRB
Address	6-18, Tenya-machi, Hakata-ku, Fukuoka city, Fukuoka, Fukuoka
Telephone	+81-92-283-7701
Approval Status	Approval
Date of approval	Feb. 05, 2026

Plan to share IPD	Yes
Plan description	Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Plan to share IPD

Yes

Plan description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Countries of Recruitment（Except Japan）	United States