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

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 A
    Absorption, distribution, metabolism, and excretion (ADME)
  • Experimental: Part B
    Bioavailability (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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