Study summary

The purpose of the study is to evaluate the pharmacokinetics (PK), safety and tolerability of multiple doses of intravenous (IV) and oral isavuconazonium sulfate administered daily in pediatric patients. The PK data will be utilized to establish a pediatric population PK model of isavuconazole, the active moiety of isavuconazonium sulfate.

Additional Study Details

Phase
1
Product
  • isavuconazonium sulfate - intravenous
  • isavuconazonium sulfate - oral
  • Type
    Interventional
    Masking
    None (Open Label)
    Enrollment number
    49
    Show Additional Study Details

    Study documents

    Scientific Results Summary
    Available Language(s): English
    Plain Language Summary
    Available Language(s): English

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    Would you like more information about clinical trial sites that are recruiting participants for A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients? Contact us by filling out your information to the right and we’ll respond to you.

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      Locations

      Contact Us
      Contact Us
      Completed
      University of Texas Southwestern Medical Center
      Dallas, TX, United States, 75235
      Completed
      Texas Children's Hospital
      Houston, TX, United States, 77030
      Withdrawn
      University of California
      San Francisco, CA, United States, 94143
      Completed
      University Hospital of Cleveland
      Cleveland, OH, United States, 44106
      Completed
      Children’s Mercy Kansas City
      Kansas City, MO, United States, 64108
      Completed
      Emory University School of Medicine
      Atlanta, GA, United States, 30322
      Completed
      Nicklaus Children's Hospital
      Miami, FL, United States, 33155
      Withdrawn
      Children’s of Alabama
      Birmingham, AL, United States, 35233
      Completed
      Children’s Hospitals and Clinics of Minnesota
      Minneapolis, MN, United States, 55404
      Completed
      University of Louisville
      Louisville, KY, United States, 40202
      Completed
      Children’s Hospital of Philadelphia
      Philadelphia, PA, United States, 19104
      Withdrawn
      Indiana University School of Medicine
      Indianapolis, IN, United States, 46202
      Withdrawn
      SUNY Upstate Medical University
      Syracuse, NY, United States, 13210
      Completed
      CHOC Children’s Hospital of Orange County
      Orange, CA, United States, 92868
      Completed
      Ann & Robert H Lurie Children’s Hospital of Chicago
      Chicago, IL, United States, 60611
      Completed
      Children's Hospital Los Angeles
      Los Angeles, CA, United States, 90027
      Withdrawn
      University of California Los Angeles
      Los Angeles, CA, United States, 90095
      Completed
      Miller Children's Hospital
      Long Beach, CA, United States, 90806
      Completed
      Cincinnati Children’s Hospital Medical Center
      Cincinnati, OH, United States, 45229
      Completed
      Duke University Medical Center
      Durham, NC, United States, 27710
      Completed
      The Children’s Hospital at TriStar Centennial Medical Center
      Nashville, TN, United States, 37203

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