Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 137882 in Healthy Male Volunteers
Condition: Healthy
Intervention: BI 137882; Placebo
Intervention description: Powder for oral solution; Powder for oral solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Enrollment: 40.0
Sex: Male
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 137882 in Healthy
      Male Volunteers
    

Eligibility criteria:

        Inclusion criteria:

          1. 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

          2. Age 21 to 50 years

          3. BMI 18.5 to 29.9 kg/m2 (Body Mass Index)

          4. Signed and dated written informed consent prior to admission to the study in
             accordance with GCP and the local legislation.

        Exclusion criteria:

          1. Any finding of the medical examination (including BP, PR and ECG) deviating from
             normal and of clinical relevance

          2. Any evidence of a clinically relevant concomitant disease

          3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          4. Surgery of the gastrointestinal tract (except appendectomy)

          5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or
             neurological disorders

          6. History of relevant orthostatic hypotension, fainting spells or blackouts.

          7. Chronic or relevant acute infections

          8. History of relevant allergy/hypersensitivity (including allergy to drug or its
             excipients)

          9. 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

         10. 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

         11. Participation in another trial with an investigational drug within two months prior to
             administration or during the trial

         12. Smoker (more than 10 cigarettes /day)

         13. Inability to refrain from smoking on trial days

         14. Alcohol abuse (more than 20 g/day)

         15. Drug abuse

         16. Blood donation (more than 100 mL within four weeks prior to administration or during
             the trial)

         17. Excessive physical activities (within one week prior to administration or during the
             trial)

         18. Any laboratory value outside the reference range that is of clinical relevance

         19. Inability to comply with dietary regimen of trial site

         20. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a
             QTc interval >450 ms);

         21. A history of additional risk factors for Torsades de points (TdP) (e.g., heart
             failure, hypokalemia, family history of Long QT Syndrome)