Pharmacokinetics and Safety of BILR 355 in Healthy Male Volunteers

Launched by BOEHRINGER INGELHEIM · Sep 30, 2014

Keywords

ClinConnect Summary

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Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy HIV negative adult male volunteers
• • 2. Age ≥18 and ≤60 years
• • 3. BMI ≥18.5 and BMI ≤29.9 kg/m2
• • 4. Ability to give signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local regulations
• Exclusion Criteria:
• • 1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• • 2. Surgery of gastrointestinal tract (except appendectomy)
• • 3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• • 4. History of relevant orthostatic hypotension, fainting spells or blackouts
• • 5. Chronic or relevant acute infections
• • 6. History of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged by the investigator
• • 7. Intake of drugs with a long half-life (\>24 hours) within at least one month prior to study drug administration and during the trial
• • 8. Use of drugs within 10 days prior to administration or during the trial which might reasonably influence the results of the trial
• • 9. Participation in another trial with an investigational drug within two months prior to administration or during the trial
• • 10. Current smoker
• • 11. Alcohol abuse (more than 60 g/day)
• • 12. Drug abuse (positive urine test for illicit prescription or non-prescription drugs or drugs of abuse)
• • 13. Blood donation (more than 100 mL within four weeks prior to study drug administration or during the trial)
• • 14. Excessive physical activities (within one week prior to study drug administration or during the trial)
• • 15. Any laboratory value outside the reference range that was of clinical relevance at screening, according to the judgment of the investigator
• • 16. Inability to comply with dietary regimen required by the protocol
• • 17. Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B surface antigen, or hepatitis C antibody positive)