A study in healthy Japanese men to test how well different doses of BI 1291583 are tolerated

JRCT ID: jRCT2071210111

Registered date:18/01/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: non-cystic fibrosis bronchiectasis (nCFB), Chronic obstructive pulmonary disease (COPD)
• Date of first enrollment: 08/03/2022
• Target sample size: 36
• Study type: Interventional

Intervention(s)

Drug: BI 1291583 (1mg, 2.5mg, 5mg)
Other: Placebo
Route: oral

Outcome(s)

• Primary Outcome: the percentage [%] of subjects with drug-related AEs per treatment group

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 45age old
• Gender: Male
• Include criteria: Healthy male subjects, age of 20 to 45 years (inclusive), body mass index (BMI) of 18.5 to 25.0 kg/m2 (inclusive)

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 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)

Related Information

• Primary Sponsor: Mizuguchi Yuto