臨床研究等提出・公開システム

Date of registration	Nov. 25, 2020
Last modified on	Nov. 25, 2020
Trial ID	jRCT2071200055

Scientific Title	Safety, tolerability and pharmacokinetics of single and multiple rising doses of BI 764198 in Japanese healthy male subjects (double-blind, randomised, placebo-controlled within dose groups, parallel group design)
Public Title	A study in healthy Japanese men to test how well different doses of BI 764198 are tolerated

Contact for Scientific Queries	Name	Ogawa Shintaro
	Affiliation	Boehringer Ingelheim
	Address	2-1-1, Osaki, Shinagawa-ku, Tokyo
	Telephone	+81-3-6417-2770
	E-mail	ctinfo@boehringer-ingelheim.com
Contact for Public Queries	Name	Takasu Yuji
	Affiliation	Boehringer Ingelheim
	Address	2-1-1, Osaki, Shinagawa-ku, Tokyo
	Telephone	+81-3-6417-2770
	E-mail	ctinfo@boehringer-ingelheim.com

Recruitment status	Pending

Anticipated date of first enrollment		Jan. 22, 2021
Target sample size		44
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Healthy male subjects, age of 20 to 45 years (inclusive), body mass index (BMI) of 18.5 to 25.0 kg/m2 (inclusive)
	Exclusion Criteria	1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator 2. Repeated measurement of systolic blood pressure outside the range of 90 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 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
	Age Minimum	20age 0month 0week old over
	Age Maximum	45age 0month 0week old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		NA
Intervention(s)		IMP (BI 764198) administration and laboratory test etc.. Oral daily dose, once per day.
Primary Outcome(s)		Percentage of subjects with drug-related adverse events
Secondary Outcome(s)		Pharmacokinetic parameters will be determined if feasible

Primary Sponsor	Boehringer Ingelheim

Name of Certified Review Board	Hakata Clinic IRB
Address	6-18, Tenyamachi, Hakata-ku, Fukuoka, Fukuoka
Telephone	+81-92-283-7701
E-Mail	ctinfo@boehringer-ingelheim.com
Approval Status	Not approval

Plan to share IPD	Yes
Plan description	Researchers can refer to https://trials.boehringer-ingelheim.com/ to request access to raw data from our clinical studies.

Countries of Recruitment（Except Japan）	none