Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of Single Escalating Doses of BI 1034020 Administered Intravenously or Subcutaneously to Male Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Investigation of safety and tolerability of BI 1034020 in healthy male volunteers following intravenous (IV) infusion of subcutaneous (SC) injection of single doses and exploration of the pharmacokinetics and pharmacodynamics of BI 1034020 after single dosing and determination of the bioavailability of subcutaneous injections of BI 1034020

Official Title
-----------------
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Intravenous and Subcutaneous Doses of BI 1034020 in Healthy Male Volunteers (Partially Randomised, Single-blind, Placebo-controlled Within Dose Groups, Clinical Phase I Study)

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: BI 1034020
* Drug: Placebo to BI 1034020


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Healthy males based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests Age within the range of 18 to 40 years Body mass index within the range of 18.5 and 29.9 kg/m2 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 blood pressure, pulse rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator. Pulse rate outside the range of 50-90 bpm or blood pressure outside the ranges of 90-140 for systolic and 50-90 mmHg for diastolic blood pressure if confirmed by repeat measurement Any evidence of a clinically relevant concomitant disease. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders. Surgery of the gastrointestinal tract (except appendectomy). Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders. History of relevant orthostatic hypotension, fainting spells or blackouts. Chronic or relevant acute infections.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 1034020 intravenous part<br>single rising doses | Drug: BI 1034020<br>* intravenous part<br>Drug: Placebo to BI 1034020<br>* intravenous part<br>|
| Experimental: BI 1034020 subcutaneous part<br>single rising doses | Drug: BI 1034020<br>* intravenous part<br>Drug: Placebo to BI 1034020<br>* intravenous part<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Drug Related Adverse Events | Percentage of subjects with investigator defined drug-related adverse events | from the first drug administration to end of trial, up to 50 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum measured concentration of BI 1034020 in plasma (Cmax). | 2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1. | 
| AUC0-inf | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). AUC0-inf could be assessed only in 50 mg iv dose group as terminal phase was below lower limit of quantification (BLQ) for other dose groups. Therefore dose proportionality for AUC0-inf could not be performed in this trial. | 2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1. | 
| AUC0-tz | Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose (AUC0-tz ). | 2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1. |