Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655130 in Healthy Male Volunteers

Study Overview
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Brief Summary
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The primary objective of this trial is to investigate the safety and tolerability of BI 655130 in healthy male subjects following IV administration of multiple rising doses. The study will also explore safety and tolerability following a single IV administration.

Official Title
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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Intravenous Doses of BI 655130 (Double-blind, Partially Randomised Within Dose Groups, Placebo-controlled Parallel Group Design) and One Single Intravenous Dose of BI 655130 (Single-blind, Partially Randomised, Placebo-controlled) in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 655130
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy male subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP - Blood Pressure, PR - Pulse Rate), 12-lead ECG (Electrocardiogram), and clinical laboratory tests Age of 18 to 50 years (incl.) BMI of 18.5 to 29.9 kg/m2 (incl.) Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation Exclusion criteria: Any finding in the medical examination (including BP - Blood Pressure, PR - Pulse Rate or ECG - Electrocardiogram) is deviating from normal and judged 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 45 to 90 bpm Any laboratory value outside the reference range that the investigator considers to be of clinical relevance Any evidence of a concomitant disease judged 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 Further exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 655130<br> | Drug: BI 655130<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with drug related adverse events |  | up to 1920 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single dose part: AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) |  | up to 1752 hours | 
| Single dose part: Cmax (maximum measured concentration of the analyte in plasma) |  | up to 1752 hours | 
| Multiple dose part: After the first dose: AUCtau,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval tau after administration of the first dose) |  | up to 1920 hours | 
| Multiple dose part: After the first dose: Cmax (maximum measured concentration of the analyte in plasma) |  | up to 1920 hours | 
| Multiple dose part: After the last dose: - AUCtau,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau) |  | up to 1920 hours | 
| Multiple dose part: After the last dose: Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau) |  | up to 1920 hours |