A Study in Healthy Men to Test How BI 1569912 is Processed in the Body

NCT ID: NCT06520553

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-26
• Study Completion Date: 2024-10-03

Brief Summary

The main objectives of this trial are:

• To investigate basic pharmacokinetics of BI 1569912 and total radioactivity, including mass balance, excretion pathways and metabolism following oral administration of BI 1569912 (C-14) to healthy male subjects (test treatment, T).
• To investigate the absolute bioavailability of BI 1569912 as single oral solution dose, using a single, concomitant intravenous micro-tracer administration of BI 1569912 (C-13) (reference treatment, R)

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BI 1569912 (C-14) followed by BI 1569912 (C-13)

BI 1569912 (C-14) = \[test treatment, T\] BI 1569912 (C-13) = \[reference treatment, R\]

Group Type: EXPERIMENTAL

BI 1569912 (C-14)

Intervention Type: DRUG

unlabelled BI 1569912 mixed with \[14C\]- labelled BI 1569912

BI 1569912 (C-13)

Intervention Type: DRUG

\[13C\]- labelled BI 1569912

Interventions

BI 1569912 (C-14)

unlabelled BI 1569912 mixed with \[14C\]- labelled BI 1569912

Intervention Type: DRUG

BI 1569912 (C-13)

\[13C\]- labelled BI 1569912

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Subjects will only be included in the trial if they meet the following criteria:

1. Healthy male subjects 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 29.9 kg/m 2 (inclusive)

4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Exclusion Criteria

Subjects will not be allowed to participate, if any of the following general criteria apply:

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, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 40 to 100 beats per minute (bpm)

3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular hepatic parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin) or renal parameters (creatinine) exceeding the upper limit of normal (ULN) after repeated measurements

4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator

• 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

ICON-Groningen-62040

Groningen, , Netherlands

Countries

Netherlands

Related Links

http://www.mystudywindow.com

Related Info

Other Identifiers

2023-510464-12-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1302-4229

Identifier Type: REGISTRY

Identifier Source: secondary_id

1447-0010

Identifier Type: -

Identifier Source: org_study_id