A Study to Test How BI 1819479 is Taken up and Processed by the Body

Boehringer Ingelheim

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: BI 1819479 (C-14); Drug: [14C]BI 1819479; Drug: BI 1819479

Study type: Interventional

Funder types: Industry

Identifiers

NCT07065617

1462-0007

Details and patient eligibility

About

This trial is intended to investigate the mass balance, metabolism, and basic pharmacokinetics of BI 1819479 (C-14) (Part A) and to investigate the absolute bioavailability of BI 1819479 (Part B) in healthy male volunteers.

Enrollment: 14 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male 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 without any clinically significant abnormalities
2. Age of 18 to 55 years (inclusive)
3. Body Mass Index (BMI) of 18.5 to 32.0 kg/m^2 (inclusive)
4. Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
5. Must have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day), applicable to Part A only

Exclusion criteria

1. Any finding in the medical examination (including vital signs 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, diastolic blood pressure outside the range of 40 to 90 mm Hg, or heart rate outside the range of 45 to 90 bpm (beats per minute)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, assessed as clinically relevant by the investigator
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Part A: BI 1819479 (C-14)

Experimental group

Treatment:

Drug: BI 1819479 (C-14)

Part B: BI 1819479, then [14C]BI 1819479

Experimental group

Treatment:

Drug: BI 1819479

Drug: [14C]BI 1819479