None listed
Conditions
Interventions
one dose of BI 1015550(9mg or 18mg)
Sponsors
Mochizuki Toko
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Healthy male subjects, age of 18 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, RR 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 40 to 90 mmHg, or PR outside the range of 40 to 99 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 -Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix -Inability to comply with the dietary regimen of the trial site -A marked prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in male) or any other relevant ECG finding at screening. -A history of additional risk factors for Torsade de Pointes (such as heart failure, hypokalaemia, or family history of Long QT Syndrome) -Any lifetime history of suicidal behavior (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior) -History of vasculitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity -Cmax (maximum measured concentration of the analyte in plasma) | — |
Countries
Japan, none
Contacts
Public ContactTomohiro Yamagami
Boehringer Ingelheim
Outcome results
None listed