Clinical Trial Details

Overview

Research Study Summary

A Phase 1, Single-Administration Pharmacokinetic and Safety Study of Oral and IV Tedizolid Phosphate in Hospitalized Subjects 2 to 12 Years Old

Purpose
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).
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CW ID: 223059
Date Last Changed: February 10, 2017

Clinical Trial Snapshot

Phase
1
Gender
Both Male and Female
Age
N/A
Overall Status
Recruiting
Lead Sponsor
Merck Sharp & Dohme Corp
Facility Type
N/A

Eligibility

Inclusion Criteria:
  • Receiving prophylaxis for or with a confirmed or suspected infection with Gram-positive bacteria and receiving concurrent antibiotic treatment with Gram-positive antibacterial activity;
  • Weight >5th percentile and <95th percentile based on age;
  • Stable condition as determined from medical history, physical examination, minimally 5-lead ECG, vital signs, and clinical laboratory evaluations;
  • Females must be premenarchal, abstinent, or practicing an effective method of birth control.
Exclusion Criteria:
  • History of seizures, other than febrile seizures, clinical significant cardiac arrhythmia, cystic fibrosis, moderate or severe renal impairment, or any physical condition that could interfere with the study results;
  • Recent (3 month) history or current infection with viral hepatitis or other significant hepatic disease;
  • History of drug allergy or hypersensitivity to oxazolidinones;
  • Pregnant or breast feeding;
  • Significant blood loss within 60 days prior to study start;
  • Any acute or chronic condition that would limit the participant's ability to complete and/or participate in this clinical study.
  • Treatment with investigational medicinal product within 30 days before the infusion/dose of study drug.
  • Oral administration of methotrexate, topotecan, irinotecan or rosuvastatin, during administration of oral study drug. Administration during the follow-up period is allowed, as is administration during treatment with IV study drug.

Contact

Denise Casey
University of South Florida - Tampa General Hospital
1 Tampa General Circle
Tampa, FL 33606
Phone: (813) 259-8674

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