NCT07273474

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

December 30, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2026

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2026

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

November 27, 2025

Last Update Submit

March 30, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

Part A

EXPERIMENTAL

Absorption, distribution, metabolism, and excretion (ADME)

Drug: BI 3000202Drug: BI 3000202 [14C]-labelled

Part B

EXPERIMENTAL

Bioavailability (BA)

Drug: BI 3000202Drug: BI 3000202 [14C]-labelled

Interventions

BI 3000202DRUG

BI 3000202 unlabelled

Part APart B
BI 3000202 [14C]-labelledDRUG

BI 3000202 \[14C\]-labelled

Part APart B

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICON-Groningen-62040

Groningen, 9728 NZ, Netherlands

Location

Related Links

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2025

First Posted

December 9, 2025

Study Start

December 30, 2025

Primary Completion

March 5, 2026

Study Completion

March 25, 2026

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Locations

NL(1)