臨床研究等提出・公開システム

Safety, tolerability and pharmacokinetics of single rising oral doses and
multiple oral doses of BI 1569912 in healthy male Japanese subjects
(single-blind, partially randomized within dose groups, placebocontrolled,
parallel-group design)

A study in healthy Japanese men to test how well different doses
of BI 1569912 are tolerated

Furuichi Takumi

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

medchiken.jp@boehringer-ingelheim.com

Tachibana Yoshifumi

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Toko

+81-120-189-779

medchiken.jp@boehringer-ingelheim.com

Complete

July. 21, 2021

Interventional

randomized controlled trial

single blind

placebo control

parallel assignment

treatment purpose

Healthy male subjects according to the assessment of the investigator, as based on a
complete medical history including a medical examination, vital signs (BP, PR), 12-lead
ECG, and clinical laboratory tests
Japanese ethnicity
BMI of 18.5 to 25.0 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the study, in accordance
with GCP and local legislation

Any finding in the medical examination (including BP, PR or ECG) deviating from
normal and assessed as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg,
diastolic blood pressure outside the range of 40 to 90 mmHg, or pulse rate outside the
range of 40 to 99 bpm
Any laboratory value outside the reference range that the investigator considers to be of
clinical relevance
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

Male

Major Dipressive Disorder

Drug: BI1569912
Other: Placebo

the percentage [%] of subjects with drug-related AEs per treatment group

+81-92-283-7701

June. 18, 2021

Yes

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

none