臨床研究等提出・公開システム

Date of registration	Dec. 11, 2017
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080223748

Scientific Title	Phase 1 study of DS-3201b to evaluate the pharmacokinetics and safety after single oral administration, the relative bioavailability after administration of tablet and capsule formulations, and the effect of food on the pharmacokinetics in healthy Japanese subjects
Public Title

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHI SANKYO Co.,Ltd.
	Address	dsclinicaltrial@daiichisankyo.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		50
Study Type		Interventional
Study Design	Study Design	Part 1: Open label, single parallel-group ascending dose study Part 2: randomized, open-label, single-dose, 2-group 2-period crossover study
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	Part 1 & 2 1. Japanese males 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	Part 1 & 2 1. Having a history of hypersensitivity to drugs or other substances or being idiosyncratic (eg, having penicillin allergy) 2. Having alcohol or drug dependence
	Minimum Age	20age old over
	Maximum Age	45age old under
	Gender	Male
Health Condition or Problem Studied		Healthy volunteers
Intervention(s)		investigational material(s) Generic name etc : DS-3201b INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Single oral administration, 50-200 mg
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Part 1: Safety, Part 2: Pharmacokinetics
Secondary Outcome		Part 1: Pharmacokinetics, Part 2: Safety

Primary Sponsor	DAIICHI SANKYO CO., LTD.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-173804
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	June. 25, 2018	Detail	Changes
5	June. 25, 2018	Detail	Changes
4	April. 20, 2018	Detail	Changes
3	April. 20, 2018	Detail	Changes
2	Dec. 11, 2017	Detail	Changes
1	Dec. 11, 2017	Detail

List of change history