First in Man Trial of BI 113608

Study Overview
=================
Brief Summary
-----------------
The primary objective of the current study is to investigate the safety and tolerability of BI 113608 in healthy male volunteers following oral administration of single rising doses. A secondary objective is the exploration of the pharmacokinetics of BI 113608 after single dosing.

Official Title
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Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 113608 in Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 113608
* Drug: BI 113608
* Drug: BI 113608
* Drug: BI 113608
* Drug: Placebo
* Drug: BI 113608
* Drug: BI 113608
* Drug: BI 113608
* Drug: BI 113608
* Drug: BI 113608
* Drug: BI 113608


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 1. Healthy male subjects Exclusion criteria: 1. Any relevant deviation from healthy conditions

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 113608 high dose 1<br>Powder for oral solution | Drug: BI 113608<br>* High dose powder for oral solution<br>|
| Experimental: BI 113608 low dose 1<br>Powder for oral solution | Drug: BI 113608<br>* Low dose powder for oral solution<br>|
| Experimental: BI 113608 low dose 2<br>Powder for oral solution | Drug: BI 113608<br>* Low dose powder for oral solution<br>|
| Experimental: BI 113608 low dose 4<br>Powder for oral solution | Drug: BI 113608<br>* Low dose powder for oral solution<br>|
| Experimental: BI 113608 low dose 5<br>Powder for oral solution | Drug: BI 113608<br>* Low dose powder for oral solution<br>|
| Experimental: BI 113608 medium dose 1<br>Powder for oral solution | Drug: BI 113608<br>* Medium dose powder for oral solution<br>|
| Experimental: BI 113608 medium dose 2<br>Powder for oral solution | Drug: BI 113608<br>* Medium dose powder for oral solution<br>|
| Experimental: BI 113608 medium dose 3<br>Powder for oral solution | Drug: BI 113608<br>* Medium dose powder for oral solution<br>|
| Experimental: BI 113608 high dose 2<br>Powder for oral solution | Drug: BI 113608<br>* High dose powder for oral solution<br>|
| Experimental: BI 113608 high dose 3<br>Powder for oral solution | Drug: BI 113608<br>* High dose powder for oral solution<br>|
| Placebo Comparator: Placebo<br>Powder for oral solution | Drug: Placebo<br>* Powder for oral solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, Lung Function, Carbon Monoxide Diffusing Capacity of the Lung, ECG, Physical Examination, Orthostasis Test, Oxygen Saturation or Haemoccult Test | Clinically relevant abnormalities for clinical laboratory evaluation, vital signs, lung function, carbon monoxide Diffusing Capacity Of the Lung (DLCO), Electrocardiogram (ECG), physical examination, orthostasis test, oxygen saturation or haemoccult test | From administration of study drug until end-of-study visit, up to 10 days | 
| Percentage of Participants With Drug-related Adverse Events | Percentage of participants with drug-related adverse events | From administration of study drug until end-of-study visit, up to 10 days | 
| Assessment of Tolerability by the Investigator | Assessment of tolerability by the investigator assessed according to the categories good, satisfactory, not satisfactory, bad and not assessable. | End of study visit, up to day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum measured concentration of the analyte in plasma (Cmax). The analysis population was the pharmacokinetic (PK) set which included all subjects randomised and treated with study medication who provided at least 1 evaluable observation for a PK endpoint of Area Under the Concentration-time Curve from 0 to infinity (AUC0-inf), Area Under the Concentration-time Curve from 0 to the last quantifiable data point (AUC0-tz) and Cmax and who had no important protocol violations relevant to the evaluation of PK. | Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration | 
| Tmax | Time from dosing to maximum measured concentration of the analyte in plasma (Tmax) | Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration | 
| AUC0-tz | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) | Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration | 
| AUC0-infinity | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) | Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration | 
| t1/2 | Terminal half-life of the analyte in plasma (t1/2) | Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration |