Gram-positive bacterial infection MedDRA version: 18.1 Level: LLT Classification code 10053021 Term: Gram-positive bacterial infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Sivextro
Product Name: tedizolid
Pharmaceutical Form: Powder for injection
INN or Proposed INN: tedizolid
CAS Number: 856867-55-5
Current Sponsor code: MK-1986/TR-701
Other descriptive n
Sponsors
Cubist Pharmaceuticals LLC
Eligibility
Sex/Gender
All
Inclusion 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; 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
United States
Contacts
Public ContactPamela Sears
Cubist Pharmaceuticals LLC
Outcome results
None listed