Safety Tolerability and Pharmacokinetic of BI 409306

Study Overview
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Brief Summary
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The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in healthy male genotyped volunteers following oral administration of single rising doses. The secondary objectives are: (1) to explore dose proportionality of BI 409306 as immediate release solid oral dosage, (2) to explore the relative bioavailability of BI 409306 when administered as immediate release solid oral dosage compared to oral drinking solution and (3) to compare the safety and pharmacokinetic profiles between two different groups of genotyped subjects.

Official Title
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A Randomized, Double-blind, Placebo-controlled (Within Dose Groups) Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Doses 0.5 mg to 500 mg of BI 409306 Administered Orally in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Placebo
* Drug: Placebo .
* Drug: BI 409306


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests Age > 21 and Age < 50 years Body Mass Index (BMI) > 18.5 and BMI < 29.9 kg/m2 Exclusion criteria: Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance 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 (including but not limited to any kind of seizures, stroke or psychiatric disorders) within the past 6 month History of relevant orthostatic hypotension, fainting spells or blackouts. Chronic or relevant acute infections History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial Any laboratory value outside the reference range that is of clinical relevance A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms); A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

Ages Eligible for Study
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Minimum Age: 21 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 409306 dose 1<br>Solution for oral administration | Drug: BI 409306<br>* Immediate release solid oral dosage medium<br>|
| Experimental: BI 409306 dose 2<br>Solution for oral administration | Drug: BI 409306<br>* Immediate release solid oral dosage medium<br>|
| Experimental: BI 409306 dose 3<br>Solution for oral administration | Drug: BI 409306<br>* Immediate release solid oral dosage medium<br>|
| Experimental: BI 409306 dose 4<br>Solution for oral administration | Drug: BI 409306<br>* Immediate release solid oral dosage medium<br>|
| Experimental: BI 409306 dose 5<br>Immediate release solid oral dosage | Drug: BI 409306<br>* Immediate release solid oral dosage medium<br>|
| Experimental: BI 409306 dose 6<br>Immediate release solid oral dosage | Drug: BI 409306<br>* Immediate release solid oral dosage medium<br>|
| Experimental: BI 409306 dose 7<br>Immediate release solid oral dosage | Drug: BI 409306<br>* Immediate release solid oral dosage medium<br>|
| Experimental: BI 409306 dose 8<br>Immediate release solid oral dosage | Drug: BI 409306<br>* Immediate release solid oral dosage medium<br>|
| Experimental: BI 409306 dose 9<br>Immediate release solid oral dosage | Drug: BI 409306<br>* Immediate release solid oral dosage medium<br>|
| Experimental: BI 409306 dose 10<br>Immediate release solid oral dosage | Drug: BI 409306<br>* Immediate release solid oral dosage medium<br>|
| Experimental: BI 409306 dose 11<br>Immediate release solid oral dosage | Drug: BI 409306<br>* Immediate release solid oral dosage medium<br>|
| Experimental: BI 409306 dose 12<br>Immediate release solid oral dosage | Drug: BI 409306<br>* Immediate release solid oral dosage medium<br>|
| Placebo Comparator: Placebo<br>Solution for oral administration | Drug: Placebo<br>* Solution for oral administration<br>|
| Placebo Comparator: Placebo 2<br>Immediate release solid oral dosage | Drug: Placebo .<br>* Immediate release solid oral dosage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical examination (respiratory, gastro-intestinal, musculoskeletal) |  | 18 weeks | 
| Vital signs |  | 18 weeks | 
| 12-lead ECG (electrocardiogram) |  | 18 weeks | 
| Clinical laboratory tests (haematology: haemoglobin; haematocrit/erythrocytes; haemoglobin/erythroctes; Erythro-, leuco-,lympho-, mono-Cytes; Platelets) |  | 18 weeks | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | 18 weeks | 
| Assessment of tolerability by investigator |  | 18 weeks | 
| Clinical laboratory tests (clinical chemistry: electrolytes;liver enzymes, bilirubin, amylase, lipase, cholesterol) |  | 18 weeks | 
| Clinical laboratory tests (urinanalysis: pH, nitrite, protein, glucose, ketones, red blood cells, white blood cells, bacteria, crystals) |  | 18 weeks | 
| Changes from baseline in Bond-Lader Visual Analogue Scales |  | Up to 24 h after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (maximum measured concentration of the analyte in plasma) |  | 18 weeks | 
| AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) |  | 18 weeks | 
| AUC0-tz (area under the concentration-time curve of the analyte in plasma from time 0 to time of last quantifiable data point) |  | 18 weeks | 
| Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) |  | 18 weeks |