Healthy
Conditions
Brief summary
The goal of this study is to find out how BI 1584862 moves through and exits the body of healthy men. To do this, BI 1584862 is labelled using radioactive carbon (C-14) and using a non-radioactive, naturally occurring, stable isotope (C-13). The study will measure how much of the study medicine is recovered in urine and faeces after taking it by mouth. It will also look at how much of the study medicine enters the bloodstream when taken by mouth compared to a small dose given directly into the bloodstream. The study staff measures the amount of BI 1584862 and its broken-down parts in the blood, the urine, and the stool.
Interventions
DRUG[13C]-labeled BI 1584862
\[13C\]-labeled BI 1584862, Reference treatment
DRUGUnlabeled BI 1584862 mixed with [14C]-labeled BI 1584862
BI 1584862 (C-14), Test treatment
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 according to the assessment of 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. 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 admission to the trial
Exclusion criteria
1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant 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 that the investigator considers to be of clinical relevance 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fraction excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (feurine,0-tz) | Up to Day 14 | hADME part |
| Fraction excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fefaeces,0-tz) | Up to Day 14 | hADME part |
| Sum of feurine,0-tz and fefaeces,0-tz (total recovery of [14C]-radioactivity) | Up to Day 14 | hADME part |
| Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity in plasma) of BI 1584862 after a single oral administration of BI 1584862 (C-14) (AUC0-∞) | Up to day 13 | BA part |
| Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity in plasma) of [13C]-BI 1584862 after a single intravenous infusion of BI 1584862 (C-13) (AUC0-∞) | Up to Day 6 | BA part |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax (maximum measured concentration of the analyte in plasma) of BI 1584862 after a single oral administration of BI 1584862 (C-14) | Up to Day 13 | hADME and BA part |
| AUC0-tz (area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point in plasma) of BI 1584862 after a single oral administration of BI 1584862 (C-14) | Up to Day 13 | hADME and BA part |
| Cmax of [14C]-radioactivity after a single oral administration of BI 1584862 (C-14) | Up to Day 13 | hADME part |
| AUC0-tz of [14C]-radioactivity after a single oral administration of BI 1584862 (C-14) | Up to Day 13 | hADME part |
| Cmax of [13C]-BI 1584862 after a single intravenous administration of BI 1584862 (C-13) | Up to Day 6 | BA part |
| AUC0-tz of [13C]-BI 1584862 after a single intravenous administration of BI 1584862 (C-13) | Up to Day 6 | BA part |
Countries
Netherlands
Outcome results
None listed