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

Safety, tolerability, and pharmacokinetics of single rising oral doses and multiple oral doses of BI 1291583 in healthy male Japanese subjects (double-blind, randomised, placebo-controlled, parallel group design)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2071210111
Enrollment
36
Registered
2022-01-18
Start date
2022-03-08
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-cystic fibrosis bronchiectasis (nCFB), Chronic obstructive pulmonary disease (COPD)

Interventions

Drug: BI 1291583 Other: Placebo Route: oral

Sponsors

Mizuguchi Yuto
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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

Exclusion 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)

Design outcomes

Primary

MeasureTime frame
the percentage [%] of subjects with drug-related AEs per treatment group

Contacts

Public ContactYuji Takasu

Boehringer Ingelheim

ctinfo@boehringer-ingelheim.com+81-120189779

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026