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

NCT ID: NCT07065617

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-04
• Study Completion Date: 2025-11-04

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A: BI 1819479 (C-14)

Group Type: EXPERIMENTAL

BI 1819479 (C-14)

Intervention Type: DRUG

BI 1819479 mixed with \[14C\]BI 1819479

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

Group Type: EXPERIMENTAL

[14C]BI 1819479

Intervention Type: DRUG

\[14C\]BI 1819479

BI 1819479

Intervention Type: DRUG

BI 1819479

Interventions

[14C]BI 1819479

\[14C\]BI 1819479

Intervention Type: DRUG

BI 1819479

BI 1819479

Intervention Type: DRUG

BI 1819479 (C-14)

BI 1819479 mixed with \[14C\]BI 1819479

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Quotient Sciences

Nottingham, , United Kingdom

Countries

United Kingdom

Related Links

http://www.mystudywindow.com

Related Info

Other Identifiers

1462-0007

Identifier Type: -

Identifier Source: org_study_id