臨床研究等提出・公開システム

Date of registration	Dec. 01, 2016
Last modified on	Dec. 24, 2019
Trial ID	jRCT2080223397

Scientific Title	Clinical Pharmacology Study of CS-3150 A single dose study to assess the absolute bioavailability and effect of food on the pharmacokinetics of CS-3150 in Japanese healthy subjects
Public Title	Clinical Pharmacology Study of CS-3150 A single dose study to assess the absolute bioavailability and effect of food on the pharmacokinetics of CS-3150 in Japanese healthy subjects

Completion Date or Terminated date	Mar. 06, 2017
Actual Enrolled Number	24
Baseline Characteristics	The subject demographics and characteristics for the safety analysis set was similar to those for the pharmacokinetic analysis set.
Participant flow	After obtaining informed consent for the study, a total of 24 subjects who were confirmed to be eligible were enrolled in the study. One subject withdrew from the study.
Adverse events	- Treatment emerged adverse events (TEAEs) were reported in 10 of 7 subjects and occurrence was 29.2% (7/24). One TEAE was considered related to the study drug. - No deaths and other serious adverse events were reported in the study. - TEAE leading to study discontinuation occurred in a single subject. The event was assessed as being related to treatment because a potential association could not be denied. - 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	- The absolute bioavailability (two-sided 95% CI) of esaxerenone after oral administration was 89.0% (86.7- 91.5) in the fasting state and 90.8% (88.3-93.2) in the postprandial state - Geometric least-squares mean ratios (two-sided 90% CIs) for PK parameters obtained after postprandial versus fasting oral administration were 1.010 (0.951-1.073) for Cmax and 1.019 (0.995-1.042) for AUClast. Furthermore, 90% CI values for both parameters were within the pre-specified range (0.80-1.25) for which food intake was judged not to affect esaxerenone PK.
Secondary Outcome Measures	Please refer to "adverse events" section since secondary outcome measures in the study are safety.
Brief summary	Absolute bioavailability of a single oral 5-mg dose of esaxerenone in healthy Japanese subjects was 89.0% in the fasting state and 90.8% in the postprandial state. Food intake does not affect esaxerenone PK. Additionally, no safety concerns were identified.
Posting of journal publication
Date of the first journal publication of results	May. 22, 2019
URL hyperlink(s) related to results and publications	https://link.springer.com/article/10.1007/s12325-019-00956-z

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. 16, 2017
Target Sample Size		24
Study Type		Interventional
Study Design	Study Design	A single-center, randomized, open-label, single dose, 3 sequence cross-over 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, Intravenous 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		bioavailability 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	Dec. 16, 2016

Secondary ID No.	JapicCTI-163452
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
8	Dec. 24, 2019	(this page)	Changes
7	Dec. 17, 2018	Detail	Changes
6	May. 25, 2017	Detail	Changes
5	May. 25, 2017	Detail	Changes
4	Mar. 16, 2017	Detail	Changes
3	Mar. 16, 2017	Detail	Changes
2	Dec. 01, 2016	Detail	Changes
1	Dec. 01, 2016	Detail

List of change history