A study in healthy Japanese and Chinese men to test how well different doses of BI 706321 are tolerated

JRCT ID: jRCT2071210105

Registered date:28/10/2021

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Crohns disease
• Date of first enrollment: 05/02/2022
• Target sample size: 60
• Study type: Interventional

Intervention(s)

Drug: BI 706321
Other: Placebo

Outcome(s)

• Primary Outcome: The percentage of subjects with drug-related adverse events

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 (Part I) or Chinese (Part II)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: Umezu Masafumi
• Secondary ID(s): NCT05183360