Safety, Tolerability and Pharmacokinetics of BI 409306 Tablets in Healthy Asian Male Volunteers

Study Overview
=================
Brief Summary
-----------------
Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 409306 tablets in healthy Chinese and Japanese male volunteers of a known genotype as specified in the study protocol.

Official Title
-----------------
Safety, Tolerability and Pharmacokinetics of Single Oral Doses of BI 409306 (Tablet) in Healthy Chinese and Japanese Male Volunteers and Multiple Oral Doses of BI 409306 (Tablet) in Healthy Japanese Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)

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

Intervention / Treatment
-----------------
* Drug: BI 409306
* Drug: BI 409306
* Drug: BI 409306
* Drug: BI 409306
* Drug: placebo
* Drug: placebo
* Drug: BI 409306


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Healthy male Chinese and Japanese volunteers Age between 20 and 45 years BMI between 18.5 and 25 kg/m2 (Body Mass Index) Known genotype as specified in the study protocol Subjects must be able to understand and comply with study requirements Exclusion criteria: 1. Any deviation from healthy condition

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo (Multiple dose part)<br>Placebo tablet | Drug: placebo<br>* placebo tablet<br>|
| Experimental: Dose 2, EM, single dose<br>Extensive Metaboliser (EM), single dose part, medium dose | Drug: BI 409306<br>* tablet<br>|
| Experimental: Dose 3, EM, single dose<br>Extensive Metaboliser (EM), single dose part, high dose | Drug: BI 409306<br>* tablet<br>|
| Experimental: Dose 3, PM, single dose<br>Poor Metaboliser (PM), single dose part, high dose | Drug: BI 409306<br>* tablet<br>|
| Experimental: Dose 3, PM, multiple dose<br>Poor Metaboliser (PM), multiple dose part, high dose | Drug: BI 409306<br>* tablet<br>|
| Placebo Comparator: Placebo (Single dose part)<br>Placebo tablet | Drug: placebo<br>* placebo tablet<br>|
| Experimental: Dose 1, EM, single dose<br>Extensive Metaboliser (EM), single dose part, low dose | Drug: BI 409306<br>* tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number (%) of subjects with drug related Adverse Events |  | up to 13 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (maximum measured concentration of the analyte in plasma) |  | up to 13 days | 
| AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) |  | up to 13 days | 
| AUC0-tz (area under the concentration-time curve of the analyte in plasma from time 0 to time of last quantifiable data point ) |  | up to 13 days |