臨床研究等提出・公開システム

Date of registration	Dec. 22, 2016
Last modified on	Dec. 24, 2019
Trial ID	jRCT2080223418

Scientific Title	A Phase 1 Study of CS-3150 Evaluation of Safety, Pharmacokinetics, and Pharmacodynamics after Single Oral Administration in Japanese Healthy Adult Male Subjects
Public Title	A Phase 1 Study of CS-3150 Evaluation of Safety, Pharmacokinetics, and Pharmacodynamics after Single Oral Administration in Japanese Healthy Adult Male Subjects

Completion Date or Terminated date	April. 19, 2011
Actual Enrolled Number	48
Baseline Characteristics	The mean age was 22 years to 24 years, mean height was 170 cm to 176 cm, mean body weight was 58 kg to 66 kg, and mean BMI was 20 to 22. No notable difference was found between the administration groups.
Participant flow	After obtaining informed consent for the study, a total of 48 subjects who were confirmed to be eligible were enrolled in the study. There were no subjects withdrawn from the study.
Adverse events	- The incidence of treatment emerged adverse events (TEAEs) was 5.6% (2/36) in the esaxerenone groups and 16.7% (2/12) in the placebo group. One TEAE was considered related to the study drug. - No deaths and other serious adverse events were reported in the study. - No clinically significant changes were found in the electrolytes or renal function test results. No clinically relevant findings were reported regarding other safety endpoint.
Primary Outcome Measures	Please refer to "adverse events" section since primary outcome measures in the study are safety.
Secondary Outcome Measures	- Systemic exposure (AUC and Cmax) of esaxerenone increased as the dose of esaxerenone increased. - Plasma renin activity, ARC, PAC, urine Na+ excretion, and urinary Na+/K+ ratio increased after the administration of esaxerenone. No obvious relationship between the changes and the esaxerenone doses was found for any of the pharmacodynamic endpoints.
Brief summary	No safety concern was noted in single oral administration of esaxerenone at a dose of 5 mg to 200 mg in Japanese healthy adult subjects.
Posting of journal publication
Date of the first journal publication of results	June. 07, 2018
URL hyperlink(s) related to results and publications	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6046505/

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	DAIICHI SANKYO Co.,Ltd.
	Address
	Phone Number
	E-mail Address	dsclinicaltrial@daiichisankyo.co.jp

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

Recruitment Status	completed

Date of First Enrolment		Jan. 14, 2011
Target Sample Size		48
Study Type		Interventional
Study Design	Study Design	A single-center, randomized, double-blind, placebo-controlled study
Study Design	Objective	other
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	1) Japanese male 2) Persons >= 20 years and =< 45 years of age at the time of informed consent 3) Persons with a body mass index (BMI; calculated by body weight [kg]/height [m]2) of >= 18.5 kg/m2 and < 25.0 kg/m2 at the screening examination
	Exclusion Criteria	1) Persons with hypersensitivity or idiosyncratic reactions to a drug, (such as penicillin allergy) 2) Persons with drug or alcohol 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 : CS-3150 INN of investigational material : esaxerenone Therapeutic category code : 214 Antihypertensives Dosage and Administration for Investigational material : Oral control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety Safety, Pharmacokinetics and Pharmacodynamics
Secondary Outcome		-

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	approved
Date of Approval by IRB	Dec. 15, 2010

Secondary ID No.	JapicCTI-163473
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
4	Dec. 24, 2019	(this page)	Changes
3	Dec. 17, 2018	Detail	Changes
2	Dec. 22, 2016	Detail	Changes
1	Dec. 22, 2016	Detail

List of change history