NCT02268279CompletedPhase 1
A Phase 1, Open-label, Multi-center Study to Determine the Pharmacokinetics and Safety of Solithromycin as Add-on Therapy in Adolescents and Children With Suspected or Confirmed Bacterial Infection
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Melinta Therapeutics, Inc.
- Enrollment
- 84
- Primary Endpoint
- Area under the plasma concentration versus time curve (AUC) of solithromycin in children and adolescents
Study Overview
Brief Summary
Pediatric study to evaluate the safety and pharmacokinetics of solithromycin (oral and intravenous) in children ages 0 to 17
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Suspected or confirmed bacterial infection with organisms against which solithromycin is expected to be active.
Exclusion Criteria
- •Serum creatinine >2 mg/dL
- •Positive pregnancy test in females of childbearing potential
- •History of intolerance or hypersensitivity to macrolide antibiotics
Arms & Interventions
solithromycin
Experimental
oral dosing (capsules and powder for suspension) by weight once per day intravenous dosing by weight once per day
Intervention: solithromycin (Drug)
Outcomes
Primary Outcomes
Area under the plasma concentration versus time curve (AUC) of solithromycin in children and adolescents
Time Frame: 5 to 7 days
Secondary Outcomes
No secondary outcomes reported
Investigators
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