臨床研究等提出・公開システム

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)

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

Mizuguchi Yuto

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

ctinfo@boehringer-ingelheim.com

Takasu Yuji

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

+81-120189779

ctinfo@boehringer-ingelheim.com

Complete

Feb. 07, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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)

Male

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

Drug: BI 1291583
Other: Placebo
Route: oral

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

+81-92-283-7701

Dec. 20, 2021

Yes

Researcheres can refer to https://trials.boehringer-ingelheim.com/ to request access to raw data from the clinical trial

none