A Phase 1 Pediatric Study for PK/Safety

Conditions: Gram-positive bacterial infection
MedDRA version: 18.1Level: LLTClassification code 10053021Term: Gram-positive bacterial infectionSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2015-004595-29-Outside-EU/EEA

Lead Sponsor: Cubist Pharmaceuticals LLC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 32

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; Stable condition as determined from medical history, physical examination, 12 lead electrocardiogram (ECG), vital signs and clinical laboratory evaluations; No clinically significant ECG abnormalities in the judgement of the Investigator; Serum creatinine within 1.5 upper limit of reference range based on age; Femailes muste be premenarchal, abstinent, or practicing an effective method of birth control.
Are the trial subjects under 18? yes
Number of subjects for this age range: 32
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

History of seizures, otaher than fevrile seizures, clinically significant cardiac arrhythmia, cystic fibrosis, moderate or severe renal impairment, or any physical condition that could interfere with the interpretation of the study results, as determined by the Investigator; Use of rifampin, monoamine oxidase inhibitors, tricyclic antidepressants, buspirone, selective serotonin reuptake inhibitors, and serotonin 5 hydroxytrptamine receptor agonists (triptans) within 14 days prior to study drug administration; Use of over the counter medications containing vasoconstrictive agents with 48 hours befor study drug administration; Pregnant or breast feeding; Recent history (3 month) or current infection with viral hepatitis or other significant hepatic disease.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To describe the single-adminstration pharmacokinetics (PK) of IV tedizolid phosphate (TZD) and its active metabolite, tedizolid, in subjects ages 6 to < 12 years (Group 1) and 2 to < 6 years (Group 2); To describe the bioavailability of tedizolid following oral TZD administration to subjects ages 6 to < 12 years (Group 3) and 2 to < 6 years (Group 4);Secondary Objective: To evaluate the safety and tolerability of IV TZD administration in subjects ages 6 to < 12 years (Group 1 ) and 2 to < 6 years (Group 2); To evaluate the safety and tolerability of oral tedizolid in subjects ages 6 to < 12 years (Group 3) and 2 to < 6 years (Group 4); To evaluate the palatability of ral TZD suspension in subjects ages 6 to < 12 years (Group 3) and 2 to < 6 years (Group 4);Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable

Secondary Outcome Measures