臨床研究等提出・公開システム

Date of registration	Aug. 06, 2018
Last modified on	April. 10, 2019
Trial ID	jRCT2080224000

Scientific Title	Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple rising oral doses of BI 690517 in healthy Japanese male subjects (double-blind, randomised, placebo-controlled within dose groups)
Public Title	A study in healthy Japanese men to test how different doses of BI 690517 are taken up in the body and how well they are tolerated

Completion Date or Terminated date	Mar. 15, 2019
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	Undecided
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	Nippon boehringer ingelheim
	Address	https://www.boehringer-ingelheim.jp/%E6%B2%BB%E9%A8%93%E3%81%AB%E9%96%A2%E3%81%99%E3%82%8B%E3%81%8A%E5%95%8F%E3%81%84%E5%90%88%E3%82%8F%E3%81%9B
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Nippon boehringer ingelheim
	Address	https://www.boehringer-ingelheim.jp/%E6%B2%BB%E9%A8%93%E3%81%AB%E9%96%A2%E3%81%99%E3%82%8B%E3%81%8A%E5%95%8F%E3%81%84%E5%90%88%E3%82%8F%E3%81%9B
	Phone Number
	E-mail Address

Recruitment Status	completed

Date of First Enrolment		Aug. 06, 2018
Target Sample Size		36
Study Type		Interventional
Study Design	Study Design	Double-blind, randomised, placebo-controlled within dose groups design
Study Design	Objective	other
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	Healthy male Japanese subjects, age of 20 to 50 years, body mass index (BMI) of 18.5 to 25.0 kg/m2
	Exclusion Criteria	1. Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator 2. Repeated measurement of systolic blood pressure outside the range of 100 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
	Minimum Age	20age old over
	Maximum Age	50age old under
	Gender	Male
Health Condition or Problem Studied		-
Intervention(s)		investigational material(s) Generic name etc : BI 690517 INN of investigational material : - Therapeutic category code : 219 Other cardiovascular agents 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 administraion
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety safety, tolerability, pharmacokinetics
Secondary Outcome		safety pharmacokinetics safety, tolerability, pharmacokinetics

Primary Sponsor	Nippon boehringer ingelheim
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	hakata clinic
Address of IRB
Phone Number of IRB	（092）283-7701
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Aug. 06, 2018

Secondary ID No.	JapicCTI-184059
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
2	April. 10, 2019	(this page)	Changes
1	Aug. 06, 2018	Detail

List of change history