Healthy
Conditions
Brief summary
The objective of this study is to investigate the effect of food on the relative bioavailability of a 50 mg BI 135585 XX tablet.
Interventions
DRUGBI 135585
one oral single dose per subject
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
\- healthy male subjects
Exclusion criteria
\- Any relevant deviation from healthy conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve of BI 135585 in plasma over the time interval from 0 hours extrapolated to infinity | up to 144 hours post treatment |
| Maximum measured concentration of the analyte in plasma of BI 135585 in plasma over the time interval from 0 hours extrapolated to infinity | up to 144 hours post treatment |
Secondary
| Measure | Time frame |
|---|---|
| %AUCtz-∞ (percentage of AUC0-∞ obtained by extrapolation) | up to 144 hours post treatment |
| tmax (time from dosing to maximum measured concentration) | up to 144 hours post treatment |
| λz (terminal rate constant in plasma) | up to 144 hours post treatment |
| t1/2 (terminal half-life of the analyte in plasma) | up to 144 hours post treatment |
| MRTpo (mean residence time of the analyte in the body after oral administration) | up to 144 hours post treatment |
| CL/F (total/apparent clearance of the analyte in plasma after extravascular administration) | up to 144 hours post treatment |
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) | up to 144 hours post treatment |
| Vital signs (blood pressure, pulse rate) | up to 14 days post treatment |
| 12-lead ECG (electrocardiogram) | up to 14 days post treatment |
| Clinical laboratory parameters (haematology, enzymes, substrates, electrolytes, hormones of the HPA axis and the thyroid gland, and urinalysis) | up to 14 days post treatment |
| Incidence and severity of Adverse events | up to 14 days post treatment |
| Assessment of tolerability by the investigator | up to 14 days post treatment |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | up to 144 hours post treatment |
| Physical examination (occurrence of findings) | up to 14 days post treatment |
Countries
Germany
Outcome results
None listed