Status:
COMPLETED
A Study in Healthy Men to Test How BI 456906 is Processed in the Body
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief Summary
This trial is intended to examine the basic pharmacokinetics of BI 456906 and total \[14C\]-radioactivity, including mass balance, excretion pathways and metabolism following a single subcutaneous (SC...
Eligibility Criteria
Inclusion
- Healthy male subjects with normal Body mass index (BMI) or otherwise healthy male subjects with overweight/obesity 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 65 years (inclusive)
- BMI of 23.0 to 34.9 kg/m2 (inclusive); body weight of at least 70 kg.
- Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Exclusion
- 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 45 to 90 mmHg, or pulse rate outside the range of 40 to 100 bpm
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
- Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
Key Trial Info
Start Date :
July 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05421338
Start Date
July 4 2022
End Date
November 17 2022
Last Update
December 14 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
ICON
Groningen, Netherlands, 9728 NZ