Safety, Tolerability and Pharmacokinetics of BI 113608 in Healthy Asian and Caucasian Male Volunteers
Condition: Healthy
Intervention: BI 113608; Placebo; BI 113608; Placebo; BI 113608; BI 113608; BI 113608; BI 113608
Intervention description: Medium dose (Multiple dosing); Placebo (Multiple dosing); Low dose (Multiple dosing); Placebo (Single dosing); High dose (Single dosing); Medium dose (Single dosing); Low dose (Single dosing); High dose (Multiple dosing)
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 98.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 113608 in
      healthy Chinese, Japanese and Caucasian male volunteers.
    

Eligibility criteria:

        Inclusion criteria:

        -Healthy male volunteers according to the following criteria: Based upon a complete medical
        history, including the physical examination, vital signs (Blood Pressure, Pulse Rate),
        12-lead Electrocardiogram, clinical laboratory tests

          -  Chinese ethnicity, Japanese ethnicity according to the following criteria Japanese;
             born in Japan, be a current Japanese passport holder, have lived outside of Japan <10
             years, and have parents and grandparents who were all born in Japan Chinese; ethnic
             Chinese, born in China or ethnic Chinese born outside of China, and a descendent of 4
             ethnic Chinese grandparents who were all born in China

          -  Caucasian

          -  Age older than 20 and younger than 45 years

          -  Normal lung function testing

          -  Normal peripheral oxygen saturation as determined by non-invasive pulse oxymetry

          -  Body Mass Index more than 18.5 and Body Mass Index less than 25 kg/m2 for Japanese and
             Chinese

          -  Body Mass Index more than 18.5 and Body Mass Index less than 29.9 kg/m2 for Caucasians

          -  Signed and dated written informed consent prior to admission to the study in
             accordance with Good Clinical Practice and the local legislation.

        Exclusion criteria:

          -  Any finding of the medical examination (including Blood Pressure, Pulse Rate and
             Electrocardiogram) 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, migraine, 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)

          -  Intake of drugs with a long half-life (> 24 hours) within at least one month or less
             than 10 half-lives of the respective drug prior to administration or during the trial

          -  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

          -  Participation in another trial with an investigational drug within two months prior to
             administration or during the trial

          -  Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)

          -  Inability to refrain from smoking on trial days

          -  Alcohol abuse (more than 20 g/day)

          -  Drug abuse

          -  Blood donation (more than 100 mL within four weeks prior to administration or during
             the trial)

          -  Excessive physical activities (within one week prior to administration or during the
             trial)

          -  Any laboratory value outside the reference range that is of clinical relevance

          -  Inability to comply with dietary regimen of trial site

          -  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 pointes (e.g., heart failure,
             hypokalemia, family history of Long QT Syndrome)