Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 691751 in Healthy Asian Male Volunteers
Condition: Healthy
Intervention: Placebo to BI 691751; BI 691751 high dose; BI 691751 middle dose; Placebo to BI 691751; BI 691751 low dose 1; Placebo to BI 691751; Placebo to BI 691751; BI 691751 low dose 2
Intervention description: Placebo to BI 691751; BI 691751 high dose; BI 691751 middle dose; Placebo to BI 691751; BI 691751 low dose 1; Placebo to BI 691751; Placebo to BI 691751; BI 691751 low dose 2
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 64.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      BI 691751 is currently being developed to inhibit growth and prevent rupture of
      atherosclerotic plaques and to consequently reduce the risk of major cardiovascular events in
      patients with established atherosclerotic disease. 1334.5 is a Pan Asian Phase 1 study to
      investigate safety, tolerability and pharmacokinetics of BI 691751 in healthy Chinese and
      Japanese male volunteers.
    

Eligibility criteria:

        Inclusion criteria:

          1. Healthy males based upon a complete medical history, including a physical examination,
             vital signs (blood pressure, pulse rate), 12-lead ECG, and clinical laboratory tests

          2. Chinese ethnicity, Japanese ethnicity according to the following criteria:

             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 Japanese; born in Japan and
             holding Japanese passport, have lived outside of Japan <10 years, and have parents and
             grandparents who were all born in Japan

          3. Age within the range of 20 to 45 years

          4. Body mass index within the range of 18.5 and 25 kg/m2

          5. Signed and dated written informed consent prior to admission to the study in
             accordance with GCP and local legislation.

        Exclusion criteria:

          1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal
             and judged clinically relevant by the investigator. Pulse rate outside the range of
             50-90 bpm or blood pressure outside the ranges of 90-140 for systolic and 50-90 mmHg
             for diastolic blood pressure if confirmed by repeat measurement.

          2. Any laboratory value outside the reference range that the investigator considers to be
             of clinical relevance

          3. Any evidence of a concomitant disease judged clinically relevant by the investigator

          4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          5. Surgery of the gastrointestinal tract that could interfere with kinetics of the study
             drug

          6. Diseases of the central nervous system (such as epilepsy), central neurological
             disorders or psychiatric disorders

          7. History of relevant orthostatic hypotension, fainting spells, or blackouts

          8. Relevant chronic or acute infections

          9. History of relevant allergy/hypersensitivity (including allergy to the trial
             medication or its excipients)

         10. Intake of drugs with a long half-life (greater than 24 hours) within 30 days or less
             than 10 half-lives of the respective drug prior to study drug administration

         11. Use of drugs that might reasonably influence the results of the trial or that might
             prolong the QT/QTc interval within 14 days prior to study drug administration

         12. Participation in another trial with investigational drug administration within 60 days
             prior to administration of trial medication

         13. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)

         14. Inability to refrain from smoking on specified trial days

         15. Alcohol abuse (consumption of more than30 g/day)

         16. Drug abuse or positive drug screen

         17. Blood donation (more than 100 mL within 30 days prior to administration of trial
             medication or intended during the trial)

         18. Intention to perform excessive physical activities within one week prior to
             administration of trial medication or during the trial

         19. Inability to comply with dietary regimen of trial site

         20. A marked baseline prolongation of QT/QTc interval (such as repeated demonstration of a
             QTc interval greater than 450 ms) or any other relevant ECG finding

         21. A history of additional risk factors for Torsades de Pointes (such as heart failure,
             hypokalemia, or family history of Long QT Syndrome)

         22. Subject is assessed by the investigator as unsuitable for inclusion, for instance,
             because considered not able to understand and comply with study requirements, or has a
             condition that would not allow safe participation in the study.