Healthy
Conditions
Brief summary
The objective of the single rising dose part (SRD) is to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising doses of BI 1060469 in healthy male subjects. The objective of the food effect part (FE) is to investigate the relative bioavailability of BI 1060469 tablets in healthy male subjects in fed or fasted state.
Interventions
single rising doses
DRUGBI 1060469
food effect
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy males based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests 2. Age within the range of 18 to 50 years 3. Body mass index within the range of 18.5 and 29.9 kg/m2 4. Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and local legislation.
Exclusion criteria
1. Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and judged clinically relevant by the investigator. Pulse rate outside the range of 50-90 bpm or blood pressure outside the ranges of 90-140 for systolic and 50-90 mmHg for diastolic blood pressure if confirmed by repeat measurement. 2. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance 3. In the SRD: serum creatinine laboratory value outside the normal range 4. Glomerular filtration rate (GFR) according to CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration)-Formula \< 60 ml/ min 5. Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections) 6. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 7. Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with drug- related adverse events. | up to 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Cmax (maximum measured concentration of BI 1060469 in plasma) | up to 2 weeks |
| AUC0-infinity (area under the concentration-time curve of BI 1060469 in plasma over the time interval from 0 extrapolated to infinity) | up to 2 weeks |
| AUC0-tz (area under the concentration-time curve of BI 1060469 in plasma over the time interval from 0 up to the last quantifiable data point) | up to 2 weeks |
Countries
Germany
Outcome results
None listed