臨床研究等提出・公開システム

Date of registration	Nov. 10, 2023
Last modified on	Aug. 23, 2024
Trial ID	jRCT2071230088

Scientific Title	Safety, tolerability, and pharmacokinetics of single rising oral doses of BI 1584862 in Japanese healthy male subjects (single- masked, randomised, placebo-controlled, parallel group design)
Public Title	A study in healthy men to test how well different doses of BI 1584862 are tolerated

Contact for Scientific Queries	Name	Wu Haoyu
	Affiliation	Boehringer Ingelheim
	Address	2-1-1, Osaki, Shinagawa-ku, Tokyo
	Telephone	+81-120-189-779
	E-mail	medchiken.jp@boehringer-ingelheim.com
Contact for Public Queries	Name	Yamagami Tomohiro
	Affiliation	Boehringer Ingelheim
	Address	2-1-1, Osaki, Shinagawa-ku, Tokyo
	Telephone	+81-120-189-779
	E-mail	medchiken.jp@boehringer-ingelheim.com

Recruitment status	Complete

Anticipated date of first enrollment		Dec. 22, 2023
Target sample size		32
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Healthy male subjects, age of 18 to 45 years (inclusive), body mass index (BMI) of 18.5 to 24.9 kg/m2 (inclusive)
	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. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 40 to 99 mmHg, or pulse rate outside the range of 40 to 99 bpm at screening visit. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance at screening visit. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
	Age Minimum	18age old over
	Age Maximum	45age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		geographic atrophy (GA)
Intervention(s)		Administrate the study Drug(BI 1584862 or Placebo) Single dose.
Primary Outcome(s)		Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator. This is expressed as the percentage of subjects treated with investigational drug who experience such an event.
Secondary Outcome(s)		AUC0-tz and Cmax of BI 1584862 in plasma

Primary Sponsor	Nippon Boehringer Ingelheim Co., Ltd.

Name of Certified Review Board	The IRB of Hakata Clinic
Address	6-18, Tenyamachi, Hakata-ku, Fukuoka, Fukuoka, Fukuoka
Telephone	+81-92-283-7701
Approval Status	Approval
Date of approval	Dec. 01, 2023

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.

Secondary ID(s)	NCT06148948
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Aug. 23, 2024	(this page)	Changes
3	May. 10, 2024	Detail	Changes
2	Dec. 22, 2023	Detail	Changes
1	Nov. 10, 2023	Detail

List of change history