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

Cubist Pharmaceuticals LLC0 个研究点目标入组 32 人开始时间: 2016年1月8日最近更新: 2016年1月11日

试验速览

暂无简介。

•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

•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.

发起方