臨床研究等提出・公開システム

Date of registration	Mar. 25, 2020
Last modified on	Mar. 24, 2022
Trial ID	jRCT2080225139

Scientific Title	Phase1 Study of TS-141 in Healthy Volunteers
Public Title	Phase1 Study of TS-141 in Healthy Volunteers

Completion Date or Terminated date	July. 13, 2015
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	Nov. 10, 2020
URL hyperlink(s) related to results and publications	https://bmcpsychiatry.biomedcentral.com/track/pdf/10.1186/s12888-020-02932-2.pdf

Plan to share IPD	No
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	Taisho Pharmaceutical Co.Ltd
	Address	3-24-1 Takada, Toshima-ku, Tokyo JAPAN
	Phone Number	-
	E-mail Address	clinical-trials@taisho.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	Taisho Pharmaceutical Co.Ltd
	Address	3-24-1, Takada, Toshima-ku, Tokyo JAPAN
	Phone Number	-
	E-mail Address	clinical-trials@taisho.co.jp

Recruitment Status	completed

Date of First Enrolment		Nov. 14, 2014
Target Sample Size		48
Study Type		Interventional
Study Design	Study Design	Open-label, single/multiple-ascending dose Study
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	Healthy Volunteers
	Exclusion Criteria	Patients with a current medical history or medical history deemed inappropriate for participation in this study
	Minimum Age	20age old over
	Maximum Age	39age old under
	Gender	Male
Health Condition or Problem Studied		-
Intervention(s)		investigational material(s) Generic name etc : TS-141 INN of investigational material : - Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administration for Investigational material : Oral control material(s) Generic name etc : Tipepidine Hibenzate INN of investigational material : Tipepidine Therapeutic category code : 224 Antitussives and expectorants Dosage and Administration for Investigational material : Oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety pharmacokinetics To investigate Pharmacokinetics parameter of TS-141 and its metabolite To investigate incidence of Treatment-emergent Adverse Events and Serious AEs, vital-sign, weight, 12-leads ECG and clinical laboratory test
Secondary Outcome		-

Primary Sponsor	Taisho Pharmaceutical Co.Ltd
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Hakata Clinic Institutional Review Board
Address of IRB	6-18 Tenyamachi Hakata-ku, Fukuoka JAPAN
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Nov. 07, 2014

Secondary ID No.	JapicCTI-205235
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
2	Mar. 24, 2022	(this page)	Changes
1	Mar. 25, 2020	Detail

List of change history