A study in healthy Japanese men to test how well different doses of BI 764198 are tolerated
Phase 1
- Conditions
- A
- Registration Number
- JPRN-jRCT2071200055
- Lead Sponsor
- Ogawa Shintaro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 44
Inclusion Criteria
Healthy male subjects, age of 20 to 45 years (inclusive), body mass index (BMI) of 18.5 to 25.0 kg/m2 (inclusive)
Exclusion Criteria
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 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of subjects with drug-related adverse events
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters will be determined if feasible