PK Study of Single-Dose ZTI-01 in Children (<12 Years of Age)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pediatric ALL
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: multiple-center, non-comparative, open-label, PK studyMasking: None (Open Label)Masking Description: Subjects <12 years of age, are assigned by age to one of five age based cohorts. Study is open label and not masked.Primary Purpose: Basic Science
Participation Requirements
- Age
- Younger than 11 years
- Gender
- Both males and females
Description
Based on pre-dose weight on Day -1, subjects weighing within the 3rd to < 97th percentile based on age - will receive a single, weight adjusted dose of ZTI-01 via continuous IV infusion or syringe pump over a 1- hour (+10 min) period. Pediatric subjects participating in this study will be assigned t...
Based on pre-dose weight on Day -1, subjects weighing within the 3rd to < 97th percentile based on age - will receive a single, weight adjusted dose of ZTI-01 via continuous IV infusion or syringe pump over a 1- hour (+10 min) period. Pediatric subjects participating in this study will be assigned to one of three cohorts based on age: Cohort 1: ? 6 years to <12 years (n=6 PK evaluable subjects) Cohort 2: ? 2 years to <6 years (n=6 PK evaluable subjects) Cohort 3: Birth to < 2 years (n=9 PK evaluable subjects), split into 3 subgroups: (3a) Birth (defined as full term: 37 weeks of gestations or greater) to < 3 mos, (3b) ? 3 mos to < 6 mos, (3c) ? 6 mos to < 24 months Cohorts 1 and 2 will be enrolled first with safety and PK data evaluated before enrolling the youngest Cohort 3. Blood for fosfomycin concentration measurement will be collected throughout the study. Safety will be assessed by monitoring adverse and serious adverse events based on medical history, vital signs, ECG, laboratory assessment and physical examination.
Tracking Information
- NCT #
- NCT03709914
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: John S Bradley, MD Rady Children's Hospital / Department of Pediatrics, University of California, School of Medicine Study Chair: Jennifer Schranz, MD Nabriva Therapeutics
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