A Trial to Evaluate the Pharmacokinetics and Safety of AVYCAZ(R) in Combination With Aztreonam
Condition: Bacterial Infection
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase I, open-label, non-randomized, single center study in 48 healthy adult male
      and female subjects, aged 18 to 45 years. This study is aimed to investigate the safety and
      pharmacokinetics of ceftazidime-avibactam (AVYCAZ) combined with aztreonam (ATM), AVYCAZ
      alone, and ATM alone. The study will have 6 arms, arms 1-4 are the single drug administration
      treatment groups and will include AVYCAZ per label dosing, AVYCAZ as a continuous infusion
      (CI), ATM per label dosing, and ATM as a CI. Arms 5 and 6 are the two AVYCAZ and ATM
      combination drug administration treatment groups. The duration of subject participation will
      be up to 44 days, and the total length of the study will be 15 months. The primary objective
      of this study is to describe the safety of two dosing regimens of AVYCAZ combined with ATM
      relative to AVYCAZ alone, and ATM alone in healthy adult subjects.
    

Detailed description: 
      This is a Phase I, open-label, non-randomized, single center study in 48 healthy adult male
      and female subjects, aged 18 to 45 years. This study is aimed to investigate the safety and
      pharmacokinetics of ceftazidime-avibactam (AVYCAZ) combined with aztreonam (ATM), AVYCAZ
      alone, and ATM alone. The study will have 6 arms, arms 1-4 are the single drug administration
      treatment groups and will include AVYCAZ per label dosing, AVYCAZ as a continuous infusion
      (CI), ATM per label dosing, and ATM as a continuous infusion (CI). Arms 5 and 6 are the two
      AVYCAZ and ATM combination drug administration treatment groups. The duration of subject
      participation will be up to 44 days, and the total length of the study will be 15 months. The
      primary objective of this study is to describe the safety of two dosing regimens of AVYCAZ
      combined with ATM relative to AVYCAZ alone, and ATM alone in healthy adult subjects. The
      secondary objectives of this study are to; 1) Characterize the PK profiles of two dosing
      regimens of AVYCAZ combined with ATM, AVYCAZ alone, and ATM alone at the population level in
      healthy adult subjects; 2) Characterize the PK profiles of two dosing regimens of AVYCAZ
      combined with ATM, AVYCAZ alone, and ATM alone following initiation of dosing on day 1 in
      healthy adult subjects; and 3) Characterize the PK profiles of two dosing regimens of AVYCAZ
      combined with ATM, AVYCAZ alone, and ATM alone following multiple daily dosing in healthy
      adult subjects.
    

Intervention name(s): AZACTAM; Ceftazidime-Avibactam
Intervention type(s): Drug; Drug
Intervention description(s): A synthetic monobactam antibiotic originally isolated from Chromobacterium violaceum; An antibacterial combination product containing ceftazidime and avibactam
Intervention MeSH terms: Ceftazidime; Avibactam; Avibactam, ceftazidime drug combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aztreonam; Ceftazidime-Avibactam; Efficacy; Healthy; Pharmacokinetics; Population; Safety