Status:
COMPLETED
A Study in Healthy Men to Test How BI 1569912 is Processed in the Body
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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 administ...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Subjects will only be included in the trial if they meet the following criteria:
- 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
- Age of 18 to 55 years (inclusive)
- Body mass index (BMI) of 18.5 to 29.9 kg/m 2 (inclusive)
- 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:
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- 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)
- 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
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- Further exclusion criteria apply
Exclusion
Key Trial Info
Start Date :
August 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06520553
Start Date
August 26 2024
End Date
October 3 2024
Last Update
November 14 2024
Active Locations (1)
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1
ICON-Groningen-62040
Groningen, Netherlands, 9728 NZ