A study in healthy Japanese men to test how well different doses of BI 3006337 are tolerated
- Conditions
- on-alcoholic Steatohepatitis
- Registration Number
- JPRN-jRCT2031230638
- Lead Sponsor
- mezu Masafumi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 36
1. 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
2. Japanese ethnicity
3. BMI of 18.5 to 25.0 kg/m2 (inclusive)
4. Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. 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
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of subjects with drug-related adverse events
- Secondary Outcome Measures
Name Time Method