Skip to main content
OpenTrials
Completed

NCT Number: NCT07273474

A Study in Healthy Men and Women to Test How BI 3000202 is Taken up and Processed by the Body

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON-Groningen-62040

Groningen, 9728 NZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Any evidence of a concomitant disease assessed as clinically significant by the investigator Further exclusion criteria apply.

Treatment and study plan

BI 3000202

Drug

BI 3000202 unlabelled

BI 3000202 [14C]-labelled

Drug

BI 3000202 [14C]-labelled

Primary outcomes

  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)

    Time frame: 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)

    Time frame: 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)

    Time frame: up to 6 days

Secondary outcomes

  1. Part A: Cmax (maximum measured concentration of the analyte)

    Time frame: up to 20 days

  2. 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)

    Time frame: up to 20 days

  3. Part B: Cmax

    Time frame: up to 6 days

  4. Part B: AUC0-tz

    Time frame: up to 6 days

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Phase I, Open-label Trial in Two Parallel Parts to Investigate Mass Balance, Metabolism, and Basic Pharmacokinetics of BI 3000202 (C-14) Administered as Oral Solution (Part A) and to Investigate Absolute Bioavailability (BA) of BI 3000202 Administered as Film Coated Tablet Together With an Intravenous Microtracer Dose of BI 3000202 (C-14) (Part B) in Healthy Male and Female Participants

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2025
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.