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:Recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:2 - 11
Updated:12/30/2018
Start Date:May 2, 2016
End Date:March 23, 2019
Contact:Toll Free Number
Phone:1-888-577-8839

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

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).

Part A (IV):

- Group 1 (Cohort 1 and Cohort 2) (6 to <12 years)

- Group 2 (Cohort 1 and Cohort 2) (2 to <6 years)

Part B (Oral Suspension):

- Group 3 (6 to <12 years)

- Group 4 (2 to <6 years)

In Cohort 1 of Group 1 (IV) participants received a single administration of tedizolid
phosphate at 5 mg/kg of total body weight. After all participants in Cohort 1 of Group 1
received study drug, a preliminary analysis of the safety and PK data was performed and
results were used to select 4 mg/kg as the appropriate dose for Cohort 2 of Group 1 and Group
3, and to select 6 mg/kg as the starting dose for the younger participants, Cohort 1 of Group
2. After all participants in Cohort 1 of Group 2 receive study drug, another preliminary
analysis of the safety and PK data will be performed and results will be used to confirm 6
mg/kg as the appropriate dose for Cohort 2 of Group 2. Similarly, the Group 4 dose will be
confirmed after data review of Group 3 results.

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.

- 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.
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