Healthy
Conditions
Brief summary
The main objectives are: * To assess mass balance by determining the extent of recovery of total \[¹⁴C\]-radioactivity in urine and faeces after a single oral dose administration of BI 1815368 (C-14) (test treatment T) in healthy male trial participants. * To investigate the absolute bioavailability of BI 1815368 using a single, concomitant intravenous micro-dose administration of BI 1815368 (C13) (reference treatment R). * To provide plasma, urine, and faecal samples
Interventions
DRUGBI 1815368 (C-14)
Unlabeled BI 1815368 mixed with \[C-14\]-labeled BI 1815368
DRUGBI 1815368 (C-13)
\[13C\]-labeled BI 1815368
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male trial participant as determined by the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests 2. Age of 18 to 55 years (inclusive) at screening 3. Body mass index (BMI) of 18.5 to 29.9 kg / m2 (inclusive) at screening 4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to any trial-related procedure
Exclusion criteria
1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as assessed by the investigator 2. 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 45 to 90 bpm 3. Any laboratory value outside the reference range as judged by the investigator 4. Any evidence of a concomitant disease considered clinically relevant by the investigator Further
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fraction of [14C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe urine,0-tz) | Up to 24 days |
| Fraction of [14C]-radioactivity excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe faeces,0-tz) | Up to 24 days |
| Sum of fe urine,0-tz and fe faeces,0-tz (total recovery of [14C]-radioactivity) | Up to 24 days |
| Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), after oral administration of BI 1815368 (C-14) | Up to 24 days |
| AUC0-∞ of [13C]- BI 1815368, after a concomitant IV infusion of BI 1815368 (C-13) | Up to 24 days |
Secondary
| Measure | Time frame |
|---|---|
| Maximum measured concentration of BI 1815368 in plasma (Cmax), after oral administration of BI 1815368 (C-14) | Up to 24 days |
| Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 to the last quantifiable data point, after oral administration of BI 1815368 (C-14) | Up to 24 days |
| Cmax of [14C]-radioactivity, after oral administration of BI 1815368 (C-14) | Up to 24 days |
| AUC0-tz of [14C]-radioactivity, after oral administration of BI 1815368 (C-14) | Up to 24 days |
| Cmax of [13C]- BI 1815368 | Up to 24 days |
| AUC0-tz of [13C]- BI 1815368 | Up to 24 days |
Countries
Netherlands
Outcome results
None listed