clinical trial · NCT03217565
A Pharmacokinetic Study of Tedizolid Phosphate in Pediatric Participants With Gram-Positive Infections (MK-1986-014)
Merck Sharp & Dohme LLC·phase1·completed·n = 47
Gram-Positive InfectionsIV Tedizolid PhosphateOral Suspension Tedizolid Phosphate
brief summary
The primary objectives of this study are to describe the single-dose, and multiple dose pharmacokinetics (PK) of intravenous (IV) tedizolid phosphate, or a single dose oral suspension of tedizolid phosphate, when administered to pediatric participants, full-term neonates, and preterm neonates.
started
Feb 6, 2019
primary completion
Mar 18, 2023
completion
Apr 6, 2023
last updated
Feb 11, 2025
detailed description
Per protocol, PK analysis in Part A Group 1 will be conducted across ages in Cohorts 1 and 2 combined: Part A Group 1 Cohort 1 + Cohort 2: 28 days to \<24 months.
official title
A Phase 1, Single- and Multiple-Dose Safety and Pharmacokinetic Study of Oral and IV Tedizolid Phosphate (MK-1986) in Inpatients Under 2 Years Old
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol