Last updated on September 2018

Pharmacokinetics of Cefepime and AAI101 in Subjects With Renal Insufficiency and Healthy Subjects

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: PK in Patients With Various Degrees of Renal Disease | PK in Patients With Various Degrees of Renal Impairment
  • Age: Between 18 - 70 Years
  • Gender: Male or Female

Main Inclusion Criteria

  • Adult male or female subjects age 18 to 70 years, inclusive
  • BMI 18.0 35.0 kg/m2, inclusive, where BMI (kg/m2) = body weight (kg) / height2 (m2) Subjects with Renal Impairment (in addition)
  • Stable renal impairment, defined as no clinically significant change in disease status, as judged by the Investigator Healthy Subjects (in addition)
  • Subjects with normal renal function as evidenced by CLcr
  • Judged to be in good health in the opinion of the Investigator on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality OR Subject has a stable disease (e.g., hypertension, hyperlipidemia, diabetes mellitus, hyperthyreosis) under medical control.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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