Safety and Pharmacokinetics of Single Rising Oral Doses of BI 224436 ZW in Healthy Male Volunteers.

Launched by BOEHRINGER INGELHEIM · Jul 7, 2014

Keywords

ClinConnect Summary

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Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy males
• • 2. Age ≥21 and Age ≤50 years
• • 3. Body Mass Index (BMI) ≥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 blood pressure (BP), pulse rate (PR) and electrocardiogram (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. HIV infection and other 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 within 10 days prior to administration or during the trial
• • 11. Participation in another trial with an investigational drug within one month prior to administration or during the trial
• • 12. Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
• • 13. Inability to refrain from smoking on trial days
• • 14. Alcohol abuse (more than 60 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 treatment period)
• • 18. Any laboratory value outside the reference range that is of clinical relevance
• • 19. A baseline prolongation of QT/QTc interval (e.g., 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. Bradycardia (PR \<60 beats/min)