A study in healthy Japanese men to test how well different doses of BI 765845 are tolerated

JRCT ID: jRCT2031230092

Registered date:26/05/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: ST segment-elevation myocardial infarction (STEMI)
• Date of first enrollment: 27/07/2023
• Target sample size: 32
• Study type: Interventional
• Intervention(s): single rising doses of investigational products BI 765845

Outcome(s)

• Primary Outcome: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator.

Key inclusion & exclusion criteria

• Age minimum: >= 18age 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 physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
Japanese ethnicity
Age of 18 to 45 years (inclusive)
BMI of 18.5 to 24.9 kg/m2 (inclusive)
Signed and dated written informed consent in accordance with ICH-Good Clinical Practice (GCP) and local legislation prior to admission to the trial

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 BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 50 to 90 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 (including any history of cardiovascular diseases such as atherosclerosis, previous myocardial infarction or angina pectoris)
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 history of stroke), and other relevant neurological or psychiatric disorders

Related Information

• Primary Sponsor: Kutsunai Mitsuru