A Study in Healthy Men and Women to Test How BI 3000202 is Taken up and Processed by the Body (NCT07273474) | Clinical Trial Compass
CompletedPhase 1
A Study in Healthy Men and Women to Test How BI 3000202 is Taken up and Processed by the Body
Netherlands12 participantsStarted 2025-12-30
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. 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
✓. Age of 18 to 55 years (inclusive)
✓. Body mass index (BMI) of 18.5 to 30 kg/m² (inclusive)
✓. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Exclusion criteria
✕. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
✕. 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)
✕. Any laboratory value outside the reference range that the investigator considers to be of clinical significance
What they're measuring
1
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)
Timeframe: up to 21 days
2
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)
Timeframe: up to 21 days
3
Part B: AUC0-∞ (area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity)