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A Single-center, Open-label, Two Sequence, Crossover Study to Investigate the Interaction Between Amikacin and POL7080 in Healthy Subjects (NCT02897869)

Single-center, open-label, 2-sequence, 3-period crossover drug-drug interaction study. Repeated doses of POL7080 and repeated doses of amikacin will be administered alone or combined. In total, 14 subjects will be enrolled to obtain at least 10 evaluable subjects. The study consists of an eligibility screening period, up to 3 treatments periods and a follow-up visit.
  • Drug: POL7080
    7 doses of POL7080 alone over 2.5 days
    • Drug: Amikacin
      3 doses of Amikacin alone over 2.5 days
      • Drug: POL7080 + Amikacin
        7 doses of POL7080 and 3 doses of Amikacin over 2.5 days
        Ages eligible for Study
        18 Years to 55 Years
        Genders eligible for Study
        Accepts Healthy Volunteers
        Accepts Healthy Volunteers
        Inclusion Criteria:
        • Healthy male and female (of non-childbearing potential) subjects between 18 to 55 years of age (inclusive)
        • BMI between 18.0-30.0 kg/m2
        • Creatinine clearance estimated by Cockroft Gault formula > 80 mL/min and < 160 ml/min (for males), or < 150ml/min (females)
        • Non smokers
        • Normal audiogram.
        Exclusion Criteria:
        • History or suspicion of alcohol and/or drug abuse in the last 5 years
        • Within 2 months prior to screening: exposure to aminoglycoside antibiotic, chemotherapy, or current use of loop diuretics
        • Regular consumption of large amounts of xanthine
        • Any medication that inhibits active tubular secretion within 4 weeks prior to first dosing
        • Infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
        • Any signs of renal impairment
        • Clinically significant abnormalities (e.g. cardiovascular, laboratory values)
        • Clinically significant abnormal ECG

        1 locations

        Germany (1)
        • Not specified
          Mönchengladbach, Germany
        31 March, 2016
        30 January, 2017
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