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

Boehringer Ingelheim

Status and phase: Enrolling; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07273474

1509-0010

2023-510345-21-00 (Registry Identifier)

U1111-1301-4856 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Part A

Experimental group

Description:

Absorption, distribution, metabolism, and excretion (ADME)

Treatment:

Drug: BI 3000202 [14C]-labelled

Drug: BI 3000202

Part B

Experimental group

Description:

Bioavailability (BA)

Treatment:

Drug: BI 3000202 [14C]-labelled

Drug: BI 3000202