A study in healthy Japanese men to test how well different doses of BI 1291583 are tolerated
- Conditions
- non-cystic fibrosis bronchiectasis (nCFB), Chronic obstructive pulmonary disease (COPD)
- Registration Number
- JPRN-jRCT2071210111
- Lead Sponsor
- Mizuguchi Yuto
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 36
Healthy male subjects, age of 20 to 45 years (inclusive), body mass index (BMI) of 18.5 to 25.0 kg/m2 (inclusive)
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 50 to 90 mmHg, or pulse rate 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 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
Chronic or relevant acute infections (including positive result of either Hepatitis A antibodies, Hepatitis B surface antigen, Hepatitis B surface antibody, Hepatitis B core antibody, Hepatitis C antibodies, HIV antigen and antibody, T-SPOT or Syphilis test at Screening)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the percentage [%] of subjects with drug-related AEs per treatment group
- Secondary Outcome Measures
Name Time Method