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

Phase 1

Completed

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
100 mg BI 765080 SC injection (T)	BI 765080	-
100 mg BI 765080 IV infusion (R)	BI 765080	-

Primary Outcome Measures

Name	Time	Method
Maximum Measured Concentration of BI 765080 in Plasma (Cmax)	Within 3 hours (h) before and 0.5h, 2h, 4h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 168h, 240h, 312h, 480h, 648h and 1320h after administration of BI 765080. Applicable only for the arm "100 mg BI 765080 SC injection (T)".	Maximum measured concentration of BI 765080 in plasma (Cmax) is reported.
Area Under the Concentration-time Curve of BI 765080 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	Within 3 hours (h) before and 0.5h, 2h, 4h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 168h, 240h, 312h, 480h, 648h and 1320h after administration of BI 765080. Applicable only for the arm "100 mg BI 765080 SC injection (T)"	Area under the concentration-time curve of BI 765080 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.

Secondary Outcome Measures

Name	Time	Method
Occurrence of Drug-related Adverse Events	From start of drug of administration until end of trial, up to 59 days.	Percentage of participants with drug-related adverse events is reported.
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	Within 3 hours (h) before and 0.5h, 2h, 4h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 168h, 240h, 312h, 480h, 648h and 1320h after administration of BI 765080. Applicable only for the arm "100 mg BI 765080 SC injection (T)".	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.