A Study in Healthy Men to Test How BI 765080 is Taken up in the Body When Given as an Injection Under the Skin Compared With an Infusion Into the Vein

Study Overview
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Brief Summary
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A study in healthy man to investigate the absolute bioavailability of 100mg BI 765080, once administered as subcutaneous (SC) injection and once administered as intravenous infusion.

Official Title
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Absolute Bioavailability, Safety, Tolerability, and Pharmacodynamics Following Subcutaneous (SC) Injection of 100 mg BI 765080 Relative to Intravenous (IV) Dose in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 765080


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Caucasian male subjects according to the assessment of the investigator, as based on a complete medical history, 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/m2 (inclusive) Signed and dated written informed consent prior to admission to the study, in accordance with Good clinical practice (GCP) and local legislation Exclusion Criteria: Any finding in the medical examination (including 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 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (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 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 Chronic or relevant acute infections Further exclusion criteria apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 765080 - Administration mode 1 (T)<br>Subcutaneous (SC) injection (Test, T) | Drug: BI 765080<br>* BI 765080<br>|
| Experimental: BI 765080 - Administration mode 2 (R)<br>Intravenous (IV) infusion (Reference, R) | Drug: BI 765080<br>* BI 765080<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) |  | Up to day 56. | 
| Cmax (maximum measured concentration of the analyte in plasma) |  | Up to day 56. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) |  | Up to day 56. | 
| Occurrence of drug-related adverse events |  | Up to day 59. |