A Study in Healthy Men and Women to Test How BI 3000202 is Taken up and Processed by the Body
- Sponsor
- Boehringer Ingelheim
- Study ID
- NCT07273474
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 55 Years
- Healthy Volunteers
- Accepted
Interventions
- BI 3000202 — DRUGBI 3000202 unlabelled
- BI 3000202 [14C]-labelled — DRUGBI 3000202 \[14C\]-labelled
Study Details
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.
Key Dates
- Start date
- Dec 30, 2025
- Status verified
- Mar 2026
- Primary completion
- Mar 5, 2026
- Completion
- Mar 25, 2026
Study Design
- Enrollment
- 12 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Part AAbsorption, distribution, metabolism, and excretion (ADME)
- Experimental: Part BBioavailability (BA)
Primary Outcome Measure
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) [ Time Frame: up to 21 days ]
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