Single Rising Dose Study of BI 655088 Administered Intravenously in Healthy Male Volunteers

Study Overview
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Brief Summary
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Investigation of safety and tolerability of BI 655088 following intravenous infusion of single rising doses and exploration of the pharmacokinetics and pharmacodynamics of BI 655088 after single dosing

Official Title
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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 655088 Administered by Intravenous Infusion in Healthy Male Subjects (Single-blind, Partially Randomised Within Dose Groups, Placebo-controlled, Parallel Group Design)

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 655088
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy male subjects Age of 18 to 50 years Body mass index (BMI) of 18.5 to 29.9 kg/m2 Additional inclusion criteria may apply Exclusion criteria: Any finding in the medical examination (including BP, PR or ECG) 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 or 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 and stroke), and other relevant neurological disorders or psychiatric disorders Additional exclusion criteria may 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 655088<br> | Drug: BI 655088<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 | The number of subjects with drug-related adverse events. | up to 99 days after start of drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Measured Concentration of BI 655088 in Plasma (Cmax) | Maximum measured concentration of BI 655088 in plasma (Cmax). Time frame for all dose groups: within 3 hours before and 10, 24, 36, 48, 72, 96, 120, 144, 168, 264, 336, 432, 504, 600, 672, 840, 1008, 1176, 1344, 1512, 1680 and 2016 hours following start of infusion. In additional, the following time points for the 2 milligram group: 0.25, 0.5, 1, 1.5, 2.25, 2.5, 3, 6, 8, 12 and 30 hours following start of infusion. | Up to 2016 hours. See endpoint description for a detailed timeframe. | 
| Area Under the Concentration-time Curve of BI 655088 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | AUC0-tz (area under the concentration-time curve of BI 655088 in plasma over the time interval from 0 to the last quantifiable data point). Time frame for all dose groups: within 3 hours before and 10, 24, 36, 48, 72, 96, 120, 144, 168, 264, 336, 432, 504, 600, 672, 840, 1008, 1176, 1344, 1512, 1680 and 2016 hours following start of infusion. In additional, the following time points for the 2 milligram group: 0.25, 0.5, 1, 1.5, 2.25, 2.5, 3, 6, 8, 12 and 30 hours following start of infusion. | Up to 2016 hours. See endpoint description for a detailed timeframe. | 
| Area Under the Concentration-time Curve of BI 655088 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf) | AUC0-∞ (area under the concentration-time curve of BI 655088 in plasma over the time interval from 0 extrapolated to infinity). Time frame for all dose groups: within 3 hours before and 10, 24, 36, 48, 72, 96, 120, 144, 168, 264, 336, 432, 504, 600, 672, 840, 1008, 1176, 1344, 1512, 1680 and 2016 hours following start of infusion. In additional, the following time points for the 2 milligram group: 0.25, 0.5, 1, 1.5, 2.25, 2.5, 3, 6, 8, 12 and 30 hours following start of infusion. | Up to 2016 hours. See endpoint description for a detailed timeframe. |