A Study of Oral and Intravenous (IV) Tedizolid Phosphate in Hospitalized Participants, Ages 2 to <12 Years, With Confirmed or Suspected Bacterial Infection (MK-1986-013)

• Status: Completed
• Trial end date: 2018-12-21
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Oxazolidinones; Tedizolid; Tedizolid phosphate; Torezolid; Torezolid phosphate

Criteria

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 electrocardiogram (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, clinically 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.

• Use of monoamine oxidase inhibitors or serotonergic agents including tricyclic antidepressants, selective serotonin reuptake inhibitors, and serotonin 5 hydroxytryptamine receptor agonists (triptans), meperidine, or buspirone within,14 days prior to study, or planned use while on study.