臨床研究等提出・公開システム

Date of registration	July. 18, 2019
Last modified on	May. 07, 2021
Trial ID	jRCT2080224789

Scientific Title	Phase I Clinical Trial of EA4017: Clinical Pharmacology Study in Healthy Adult Male Subjects
Public Title	Phase I Clinical Trial of EA4017: Clinical Pharmacology Study in Healthy Adult Male Subjects

Completion Date or Terminated date	Mar. 31, 2021
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	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	EA Pharma Co., Ltd.
	Address
	Phone Number
	E-mail Address	contact_ea@eapharma.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	EA Pharma Co., Ltd.
	Address
	Phone Number
	E-mail Address	contact_ea@eapharma.co.jp

Recruitment Status	completed

Date of First Enrolment		Aug. 27, 2019
Target Sample Size		160
Study Type		Interventional
Study Design	Study Design	Part 1 (Japanese) and 2 (Caucasian) are designed as a single-dose, placebo-controlled, randomized, asdending dose, double-blind studies. Part 3 (Japanese) and 4 (Caucasian) are designed as a open label, two-period crossover studies. Single dose of EA4017 will be orally administered in the specified order (fasted/fed or fed/fasted). Part 5 (Japanese) is designed as multiple oral doses, placebo-controlled, randomized, asdending dose, double-blind study.
Study Design	Objective	other
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	Main inclusion criteria - Non-smoking Japanese and Caucasian healthy adult males. - Body Mass Index (BMI) at screening is below. Japanese: 18.5 or more but less than 25.0 kilogram per square metre (kg/m^2) Caucasian: 18.5 or more but less than 30.0 kilogram per square metre (kg/m^2) - Written, informed consent to participate in the study based on the participant's own free will and able to comply with the requirements in the study.
	Exclusion Criteria	Main exclusion criteria - With a surgical history at screening period that may affect the pharmacokinetics of the investigational product. - Suspicion of having a clinically abnormal symptom or an organ impairment that requires treatments based on the history/complications at screening period or physical findings, vital signs, electrocardiogram findings, or laboratory values at screening or baseline period. - A history of drug allergy at screening period. - Judged by the investigator or subinvestigator to be inappropriate for the participation in this study.
	Minimum Age	20age old over
	Maximum Age	44age old under
	Gender	Male
Health Condition or Problem Studied		Healthy adult subjects
Intervention(s)		investigational material(s) Generic name etc : EA4017 INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : Oral control material(s) Generic name etc : Placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : Oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety Adverse events, laboratory values, vital signs, electrocardiogram findings, physical findings
Secondary Outcome		pharmacokinetics Plasma concentration of EA4017, urinary excretion level of EA4017, pharmacokinetics parameter of EA4017

Primary Sponsor	EA Pharma 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
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	July. 12, 2019

Secondary ID No.	JapicCTI-194869
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
4	May. 07, 2021	(this page)	Changes
3	Jan. 13, 2021	Detail	Changes
2	Oct. 01, 2019	Detail	Changes
1	July. 31, 2019	Detail

List of change history