A Phase 1, Single- and Multiple-Dose Safety and Pharmacokinetic Study of Oral and IV Tedizolid Phosphate (MK-1986) in Inpatients Under 2 Years Old

1986-014

The primary objectives of this study are to describe the single-dose, and multiple dose pharmacokinetics (PK) of intravenous (IV) tedizolid phosphate, or a single dose oral suspension of tedizolid phosphate, when administered to pediatric participants, full-term neonates, and preterm neonates.

2019-02-06

2023-03-18

2023-03-29

Completed

Early phase I

47

Inclusion Criteria: * Is receiving prophylaxis for or has a confirmed or suspected infection with gram-positive bacteria and receiving concurrent antibiotic treatment with gram -positive antibacterial activity. * Is at least 1 kg in weight. * Is in stable condition as determined from medical history, physical examination, electrocardiogram (ECG), vital signs, and clinical laboratory evaluations. * Has no clinically significant ECG abnormalities. * Has sufficient vascular access to receive trial drug, and allow for required blood draws. * Is able to receive medication by mouth, for those dosed with oral suspension; dose administration via feeding tube is acceptable. Exclusion Criteria: * Has a history of seizures, other than febrile seizures, clinically significant cardiac arrhythmia or condition, moderate or severe renal impairment, or any physical condition that could interfere with the interpretation of the study results, as determined by the Investigator. * Has used rifampin within 14 days prior to dosing. * Has used or will be using proton pump inhibitors, H2 blockers, or antacids (for participants in Part B, i.e, oral suspension dose) at any time from 24 hours prior to dosing through 24 hours after dosing.. * Has a recent (3-month) history or current infection with viral hepatitis or other significant hepatic disease. * Has a history of drug allergy or hypersensitivity to oxazolidinones. * Has had significant blood loss. * Need for oral administration of topotecan, rosuvastatin, irinotecan, or methotrexate during administration of oral study drug. * Used monoamine oxidase inhibitors (MAOIs) or serotonergic agents including tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), and serotonin 5-hydroxytryptamine receptor agonists (triptans), meperidine, or buspirone within 14 days prior to study, or planned use while on study. * Has received another investigational product within the 30 days prior to enrollment.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 47, 'type': 'ACTUAL'}}

2023-04-11