Safety Tolerability and Pharmacokinetic of BI 411034

Study Overview
=================
Brief Summary
-----------------
The primary objective of the current study is to investigate the safety, tolerability and pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of single rising doses. The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19 (Cytochrome P450) genotyped extensive metabolisers (EM). Another objective is to compare the safety and pharmacokinetic profiles between two different groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)

Official Title
-----------------
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 411034 (PIB) in Healthy Male Volunteers (Randomised, Single-blind, Placebocontrolled Within Dose Groups, Phase I Study)

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

Intervention / Treatment
-----------------
* Drug: BI 411034
* Drug: Placebo
* Drug: BI 411034
* Drug: BI 411034
* Drug: BI 411034
* Drug: BI 411034
* Drug: BI 411034
* Drug: BI 411034
* Drug: BI 411034


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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 411034 low dose - group 1<br>Solution for oral administration | Drug: BI 411034<br>* Low dose solution for oral administration<br>|
| Experimental: BI 411034 low dose - group 2<br>Solution for oral administration | Drug: BI 411034<br>* Low dose solution for oral administration<br>|
| Experimental: BI 411034 medium dose - group 3<br>Solution for oral administration | Drug: BI 411034<br>* Medium dose solution for oral administration<br>|
| Experimental: BI 411034 medium dose - group 4<br>Solution for oral administration | Drug: BI 411034<br>* Medium dose solution for oral administration<br>|
| Experimental: BI 411034 medium dose - group 5<br>Solution for oral administration | Drug: BI 411034<br>* Medium dose solution for oral administration<br>|
| Experimental: BI 411034 high dose - group 6<br>Solution for oral administration | Drug: BI 411034<br>* High dose solution for oral administration<br>|
| Experimental: BI 411034 high dose - group 7<br>Solution for oral administration | Drug: BI 411034<br>* High dose solution for oral administration<br>|
| Experimental: BI 411034 high dose - group 8<br>Solution for oral administration | Drug: BI 411034<br>* High dose solution for oral administration<br>|
| Placebo Comparator: Placebo<br>Solution for oral administration | Drug: Placebo<br>* Solution for oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Drug Related AEs | Number of participants with drug related adverse events (AEs) | From drug administration until end of trial examination, up to 13 days | 
| Clinically Relevant Abnormalities for Physical Examinations, Vital Signs, ECG, Laboratory Tests | Clinically relevant abnormalities for physical examinations, vital signs (blood pressure, pulse rate, oral body temperature, orthostasis test), 12-lead electrocardiogram (ECG) and clinical laboratory tests. Clinically relevant abnormalities are reported by the investigator as adverse events (AEs). | From drug administration until end of trial examination, up to 13 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Measured Concentration (Cmax ) | Maximum measured concentration of the analyte (BI 411034) in plasma | 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration | 
| Time to Maximum Measured Concentration (Tmax) | Time from dosing to maximum measured concentration | 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration | 
| Area Under the Curve From 0 Extrapolated to Infinity (AUC0-infinity) | Area under the concentration-time curve of the analyte (BI 411034) in plasma over the time interval from 0 extrapolated to infinity | 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration | 
| Amount of Analyte Eliminated in Urine From 0h to 4h (Ae0-4) | Amount of analyte (BI 411034) eliminated in urine from the time point 0h to time point 4h. | 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration |