臨床研究等提出・公開システム

Scientific Title	Phase 1 study of DS-3201b to evaluate the effect of food (low-fat meal) on the pharmacokinetics in healthy subjects
Public Title	Phase 1 study of DS-3201b to evaluate the effect of food (low-fat meal) on the pharmacokinetics in healthy subjects

Contact for Scientific Queries	Name	Nagao Kiminori
	Affiliation	DAIICHI SANKYO Co.,Ltd.
	Address	1-2-58, Hiromachi, Shinagawa-ku, Tokyo
	Telephone	+81-3-6225-1111
	E-mail	dsclinicaltrial@daiichisankyo.co.jp
Contact for Public Queries	Name	Contact for Clinical Trial Information
	Affiliation	DAIICHI SANKYO Co.,Ltd.
	Address	1-2-58, Hiromachi, Shinagawa-ku, Tokyo
	Telephone	+81-3-6225-1111
	E-mail	dsclinicaltrial@daiichisankyo.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Nov. 09, 2020
Actual date of first enrollment		Oct. 31, 2020
Target sample size		28
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	crossover assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	1. Gender:males or females 2. Age: >=20 and =<45 years (at the time of informed consent) 3. Body mass index (BMI) = Body weight (kg) / (Height [m])2: >=18.5 and <25.0 (at screening)
	Exclusion Criteria	1. Having a history of hypersensitivity to any drugs or substances, or being idiosyncratic (eg, having penicillin allergy) 2. Having alcohol or drug dependence etc.
	Age Minimum	20age old over
	Age Maximum	45age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Healthy subjects
Intervention(s)		Oral administration
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Pharmacokinetic parameters of plasma concentration of total DS-3201a: Cmax, AUClast, AUCinf
Secondary Outcome(s)		PK: Plasma PK parameters for DS-3201a (total and unbound concentrations) Safety: AEs, laboratory data, body weight, vital signs, and 12-lead ECGs

Primary Sponsor	DAIICHI SANKYO 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-shi, 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

List of change history