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

NCT ID: NCT07273474

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-29

Study Completion Date

2026-03-05

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A

Absorption, distribution, metabolism, and excretion (ADME)

Group Type EXPERIMENTAL

BI 3000202

Intervention Type DRUG

BI 3000202 unlabelled

BI 3000202 [14C]-labelled

Intervention Type DRUG

BI 3000202 \[14C\]-labelled

Part B

Bioavailability (BA)

Group Type EXPERIMENTAL

BI 3000202

Intervention Type DRUG

BI 3000202 unlabelled

BI 3000202 [14C]-labelled

Intervention Type DRUG

BI 3000202 \[14C\]-labelled

Interventions

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BI 3000202

BI 3000202 unlabelled

Intervention Type DRUG

BI 3000202 [14C]-labelled

BI 3000202 \[14C\]-labelled

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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
2. Age of 18 to 55 years (inclusive)
3. Body mass index (BMI) of 18.5 to 30 kg/m² (inclusive)
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Exclusion Criteria

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. 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)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical significance
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ICON-Groningen-62040

Groningen, , Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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Boehringer Ingelheim

Role: CONTACT

Phone: 1-800-243-0127

Email: [email protected]

Facility Contacts

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Boehringer Ingelheim

Role: primary

Related Links

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https://www.mystudywindow.com

Related Info

Other Identifiers

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2023-510345-21-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1301-4856

Identifier Type: REGISTRY

Identifier Source: secondary_id

1509-0010

Identifier Type: -

Identifier Source: org_study_id