At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 47 enrolled
Drug / intervention
IV Tedizolid Phosphate +1 moredrug
Likely dose
Not stated in 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- and Multiple-Dose Safety and Pharmacokinetic Study of Oral and IV Tedizolid Phosphate (MK-1986) in Inpatients Under 2 Years Old
In Brief
A Phase 1 clinical trial evaluating IV Tedizolid Phosphate and Oral Suspension Tedizolid Phosphate for Gram-Positive Infections. Completed, enrolled 47 participants across 30 sites in 5 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGram-Positive Infections
CountriesBulgaria, Colombia, Norway, United Kingdom, United States
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJul 2017
Enrollment StartFeb 2019
Primary CompletionMar 2023
Study CompletionApr 2023
TodayJul 2026
First PostedJul 14, 2017
Enrollment StartFeb 6, 2019
Primary CompletionMar 18, 2023
Study CompletionApr 6, 2023
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 9.0 years ago
Interventions
IV Tedizolid Phosphatedrug
A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered IV.
Oral Suspension Tedizolid Phosphatedrug
A single dose of tedizolid phosphate administered as an oral suspension.