Bioavailability of 3 Different Formulations of BI 207127 in Healthy Male Volunteers
Condition: Healthy
Intervention: BI 207127; BI 207127; BI 207127
Intervention description: Medium dose film-coated tablet; Medium dose film-coated tablet; Medium dose film-coated tablet
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Male
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of the current study is to investigate the relative bioavailability of
      three trial formulations of BI 207127, the trial formulation 2 (TFII), the final formulation
      (FF), and a FF modified formulation. All formulations are supplied as film-coated Tablets and
      administered as single dose treatments of BI 207127 (3 film-coated Tablets) in healthy
      volunteers, with the aim to compare the bioavailability of the three formulations. All
      treatments will be applied fed, 30 minutes after start of the intake of a standard normal
      breakfast.
    

Eligibility criteria:

        Inclusion criteria:

          1. Healthy males according to a complete medical history, including a physical
             examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead
             electrocardiogram (ECG), and clinical laboratory tests

          2. Age =21and Age =50 years

          3. Body mass index =18.5 and BMI = 29.9 kg/m2

          4. Signed and dated written informed consent prior to admission to the study in
             accordance with Good Clinical Practice (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 10 half-lifes prior
             to administration of the trial drug or during the trial

         10. Use of drugs which might reasonably influence the results of the trial 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 of the trial drug or during the trial

         12. Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)

         13. Alcohol abuse (more than 40 g/day)

         14. Drug abuse

         15. Blood donation (more than 100 mL within four weeks prior to first administration of
             the trial drug or during the trial)

         16. Excessive physical activities (within one week prior to first administration of the
             trial drug or during the trial)

         17. Any laboratory value outside the reference range that is of clinical relevance

         18. Inability to comply with dietary regimen of trial site

         19. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a
             QTc interval >450 ms)

         20. A history of additional risk factors for Torsades de points (TdP) (e.g., heart
             failure, hypokalemia, family history of Long QT Syndrome)

         21. History of photosensitivity or recurrent rash

         22. Subject is not willing to avoid sun exposure from the first administration of the
             trial drug until the end of the study.