臨床研究等提出・公開システム

Date of registration	July. 07, 2021
Last modified on	Jan. 30, 2022
Trial ID	jRCT2071210040

Scientific Title	Safety, tolerability, and pharmacokinetics of single rising oral doses of BI 474121 in healthy Japanese male subjects (doubleblind, randomised, placebo-controlled, parallel group design)
Public Title	A study in healthy men to test how BI 474121 is tolerated

Contact for Scientific Queries	Name	Takada Kumiko
	Affiliation	Boehringer Ingelheim
	Address	2-1-1, Osaki, Shinagawa-ku, Tokyo
	Telephone	+81-120-189-779
	E-mail	ctinfo@boehringer-ingelheim.com
Contact for Public Queries	Name	Watabe Aiko
	Affiliation	Boehringer Ingelheim
	Address	2-1-1, Osaki, Shinagawa-ku, Tokyo
	Telephone	+81-120-189-779
	E-mail	ctinfo@boehringer-ingelheim.com

Recruitment status	Complete

Anticipated date of first enrollment		July. 27, 2021
Actual date of first enrollment		July. 28, 2021
Target sample size		32
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 according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure[BP], PR) including body temperature, 12-lead ECG, and clinical laboratory tests at screening visit
	Exclusion Criteria	Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator at screening visit
	Age Minimum	20age old over
	Age Maximum	45age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Alzheimer disease and Cognitive impairment associated with schizophrenia
Intervention(s)		Investigational medicine : BI 474121(dose: 2.5 mg/5 mg/10 mg/20 mg)oral medication or Other: Placebo oral medication
Primary Outcome(s)		Percentage of subjects with drug-related adverse events
Secondary Outcome(s)		AUC0and Cmax of BI 474121

Primary Sponsor	Boehringer Ingelheim

Name of Certified Review Board	The IRB of Hakata Clinic
Address	6-18, Tenyamachi, Hakata-ku, Fukuoka, Fukuoka
Telephone	+81-92-283-7701
Approval Status	Approval
Date of approval	July. 12, 2021

Plan to share IPD	Yes
Plan description	Researcheres can refer to https://trials.boehringer-ingelheim.com/ to request access to raw data from the clinical trial

Secondary ID(s)	NCT04964453
Issuing Authority	Clinical Trials.gov

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Jan. 30, 2022	(this page)	Changes
2	Sept. 10, 2021	Detail	Changes
1	July. 07, 2021	Detail

List of change history