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

JRCT ID: jRCT2071210037

Registered date:23/06/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Major Dipressive Disorder
• Date of first enrollment: 21/07/2021
• Target sample size: 44
• Study type: Interventional

Intervention(s)

Drug: BI1569912
Other: Placebo

Outcome(s)

• Primary Outcome: the percentage [%] of subjects with drug-related AEs per treatment group

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 45age old
• Gender: Male

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Furuichi Takumi