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Date of registration	June. 06, 2016
Last modified on	Dec. 24, 2019
Trial ID	jRCT2080223231

Scientific Title	Clinical Pharmacology Study of CS-3150 Evaluation of the effect of repeated dose of itraconazole orally administered to healthy Japanese adult male on the pharmacokinetics of CS-3150
Public Title	Clinical Pharmacology Study of CS-3150 Evaluation of the effect of repeated dose of itraconazole orally administered to healthy Japanese adult male on the pharmacokinetics of CS-3150

Completion Date or Terminated date	Aug. 23, 2016
Actual Enrolled Number	20
Baseline Characteristics	The subject demographics and characteristics for the safety analysis set was same as those for the pharmacokinetic analysis set.
Participant flow	After obtaining informed consent for the study, a total of 20 subjects who were confirmed to be eligible were enrolled in the study. There were no subjects withdrawn from the study.
Adverse events	- Treatment emerged adverse events (TEAEs) were reported in 1 of 1 subjects and occurrence was 5.0% (1/20) in the study, which was not considered by the investigator to be causally related to treatment. - No deaths and other serious adverse events were reported in the study. - Except for the abnormal change in the laboratory values reported as TEAEs, no clinically relevant changes from baseline were seen in laboratory parameters, vital signs, or 12-lead ECG parameters.
Primary Outcome Measures	Geometric least-square mean ratios (90% CI) for Cmax, AUClast, and AUCinf for esaxerenone plus itraconazole versus esaxerenone alone were 1.126 (1.054-1.202), 1.468 (1.399-1.541), and 1.531 (1.447-1.620), respectively.
Secondary Outcome Measures	Please refer to "adverse events" section since secondary outcome measures in the study are safety.
Brief summary	When esaxerenone 2.5 mg was coadministered with itraconazole 200 mg, Cmax and AUC for esaxerenone increased by approximately 1.1 fold and 1.5-fold, respectively, compared to administration of esaxerenone alone. It was considered that there were no safety concerns when esaxerenone was administered concomitantly with itraconazole.
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

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		July. 25, 2016
Target Sample Size		20
Study Type		Interventional
Study Design	Study Design	A single-center, open-label, 1 sequence crossover 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		pharmacokinetics Pharmacokinetics and safety
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	June. 21, 2016

Secondary ID No.	JapicCTI-163286
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
10	Dec. 24, 2019	(this page)	Changes
9	Dec. 17, 2018	Detail	Changes
8	Nov. 28, 2016	Detail	Changes
7	Nov. 28, 2016	Detail	Changes
6	Aug. 01, 2016	Detail	Changes
5	Aug. 01, 2016	Detail	Changes
4	July. 19, 2016	Detail	Changes
3	July. 19, 2016	Detail	Changes
2	June. 06, 2016	Detail	Changes
1	June. 06, 2016	Detail

List of change history