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A Pharmacokinetic Study of Tedizolid Phosphate in Pediatric Participants With Gram-Positive Infections (MK-1986-014)

NCT03217565 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2025-02-11

Study results available
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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.

Conditions

  • Gram-Positive Infections

Interventions

DRUG

IV Tedizolid Phosphate

A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered IV.

DRUG

Oral Suspension Tedizolid Phosphate

A single dose of tedizolid phosphate administered as an oral suspension.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-06
Primary Completion
2023-03-18
Completion
2023-04-06
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Colombia
  • Norway
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03217565 on ClinicalTrials.gov