At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
Tedizolid Phosphate (IV) +1 moredrug
Likely dose
Tedizolid Phosphate (IV) 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Single-Administration Pharmacokinetic and Safety Study of Oral and IV Tedizolid Phosphate in Hospitalized Subjects 2 to <12 Years Old
In Brief
A Phase 1 clinical trial evaluating Tedizolid Phosphate (IV) and Tedizolid Phosphate (oral suspension) for Gram-Positive Bacterial Infections. Completed, enrolled 32 participants.
Detailed Summary
This is a study to assess the pharmacokinetics (PK) of tedizolid phosphate and its active metabolite, tedizolid, and the safety of tedizolid phosphate following administration of a single IV (Part A) or oral suspension (Part B) administration to hospitalized participants ages 6 to \<12 years (Groups 1 and 3, respectively), and 2 to \<6 years (Groups 2 and 4, respectively).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGram-Positive Bacterial Infections
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartMay 2016
Primary CompletionDec 2018
Study CompletionDec 2018
TodayJul 2026
First PostedApr 25, 2016
Enrollment StartMay 2, 2016
Primary CompletionDec 16, 2018
Study CompletionDec 21, 2018
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 10.2 years ago
Interventions
Tedizolid Phosphate (IV)drug
200 mg/vial powder for injection
Tedizolid Phosphate (oral suspension)drug
Powder for oral suspension 20 mg/mL following reconstitution