Healthy
Conditions
Brief summary
The purpose of this study is to find out how quickly and to what extent BI 3000202 is processed in the body. The purpose of Part A is to find out how 3000202 moves through and exits the body of healthy people. The purpose of Part B is to find out how much BI 3000202 gets into the blood when participants take it as a tablet compared with when they get it as an infusion. Adults between 18 and 55 years of age can take part if the study doctor determines they are healthy. The doctors regularly check participants' health. To assess the study endpoints, the study staff takes blood, urine, and stool samples.
Interventions
DRUGBI 3000202
BI 3000202 unlabelled
DRUGBI 3000202 [14C]-labelled
BI 3000202 \[14C\]-labelled
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female of non-childbearing potential trial participants 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) 3. Body mass index (BMI) of 18.5 to 30 kg/m² (inclusive) 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 (inclusive), diastolic blood pressure outside the range of 50 to 90 mmHg (inclusive), or pulse rate outside the range of 40 to 99 bpm (inclusive) 3. Any laboratory value outside the reference range that the investigator considers to be of clinical significance 4. Any evidence of a concomitant disease assessed as clinically significant by the investigator Further
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: fe-urine, 0-tz (fraction excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point) | up to 21 days |
| Part A: fe-faeces, 0-tz (fraction excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point) | up to 21 days |
| Part B: AUC0-∞ (area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity) | up to 6 days |
Secondary
| Measure | Time frame |
|---|---|
| Part A: Cmax (maximum measured concentration of the analyte) | up to 20 days |
| Part A: AUC0-tz (area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point) | up to 20 days |
| Part B: Cmax | up to 6 days |
| Part B: AUC0-tz | up to 6 days |
Countries
Netherlands
Outcome results
None listed