Safety Tolerability and Pharmacokinetic of BI 409306

Launched by BOEHRINGER INGELHEIM · Apr 27, 2011

Keywords

ClinConnect Summary

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Gender

MALE

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 and Age \< 50 years
• • 3. Body Mass Index (BMI) \> 18.5 and BMI \< 29.9 kg/m2
• 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 (including but not limited to any kind of seizures, stroke or psychiatric disorders) within the past 6 month
• • 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. 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
• • 10. Any laboratory value outside the reference range that is of clinical relevance
• • 11. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 ms);
• • 12. A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)