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

Not Applicable

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: BI 1819479 (C-14); Drug: [14C]BI 1819479; Drug: BI 1819479

• Registration Number: NCT07065617
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-07-04
• Study First Submitted QC: 2025-07-04
• Last Update Submitted: 2025-07-04
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-15
• Study Start: 2025-07-31
• Primary Completion: 2026-04-19
• Study Completion: 2026-04-19

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part A: BI 1819479 (C-14)	BI 1819479 (C-14)	-
Part B: BI 1819479, then [14C]BI 1819479	[14C]BI 1819479	-
Part B: BI 1819479, then [14C]BI 1819479	BI 1819479	-

Primary Outcome Measures

Name	Time	Method
Part A: fraction of [14C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe urine, 0-tz)	Up to 37 days.
Part A: fraction of [14C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe faeces, 0-tz)	Up to 37 days.
Part B: area under the concentration-time curve of [14C]BI 1819479 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	Up to 31 days.

Secondary Outcome Measures

Name	Time	Method
Part A: Maximum measured concentration of [14C]BI 1819479-EQ in plasma (Cmax)	Up to 36 days.
Part A: Area under the concentration-time curve of [14C]BI 1819479-EQ in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz)	Up to 36 days.
Part B: Maximum measured concentration of [14C]BI 1819479 in plasma (Cmax)	Up to 31 days.
Part B: Area under the concentration-time curve of [14C]BI 1819479 in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz)	Up to 31 days.
Part B: Maximum measured concentration of BI 1819479 in plasma (Cmax)	Up to 31 days.
Part B: Area under the concentration-time curve of BI 1819479 in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz)	Up to 31 days.