E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment or prophylaxis against Gram-positive infections |
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E.1.1.1 | Medical condition in easily understood language |
Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10052891 |
E.1.2 | Term | Skin bacterial infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Part A 1. To describe the single-dose pharmacokinetics (PK) of IV tedizolid phosphate and its active metabolite, tedizolid, when administered to pediatric subjects, aged 28 days to <24 months (Group 1 [Cohorts 1 and 2 combined]), full-term neonates aged birth to <28 days (Group 2), and preterm neonates aged birth to <28 days (Group 3). 2. To describe the multiple-dose PK of IV tedizolid phosphate and its active metabolite, tedizolid, when administered to full-term neonates aged birth to <28 days (Group 2), and preterm neonates aged birth to <28 days (Group 3). Part B 3. To describe the single-dose PK of tedizolid following oral suspension of tedizolid phosphate administration to pediatric subjects aged 28 days to <24 months (Group 4), full-term neonates aged birth to <28 days (Group 5), and preterm neonates aged birth to <28 days (Group 6).
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E.2.2 | Secondary objectives of the trial |
Part A 1. To evaluate the safety and tolerability of IV tedizolid phosphate administration in pediatric subjects aged 28 days to <24 months (Group 1 [Cohorts 1 and 2 combined]), full-term neonates aged birth to <28 days (Group 2), and preterm neonates aged birth to <28 days (Group 3). Part B 2. To evaluate the safety and tolerability of oral suspension tedizolid phosphate administration in pediatric subjects aged 28 days to <24 months (Group 4), full-term neonates aged birth to <28 days (Group 5), and preterm neonates aged birth to <28 days (Group 6).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
1.AUC0-last of tedizolid phosphate 2.AUC0-inf of tedizolid phosphate 3.Cmax of tedizolid phosphate 4.Tmax of tedizolid phosphate 5.T1/2 of tedizolid phosphate 6.AUC0-last of tedizolid 7.AUC0-inf of tedizolid 8.Cmax of tedizolid 9.Tmax of tedizolid 10.T1/2 of tedizolid
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
IV Treatment: after the end of infusion, 1.5, 3, 6, 12, 24 hours after the start of infusion; Oral Suspension Treatment: 1, 3, 5, 8, 12, and 24 hours postdose |
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E.5.2 | Secondary end point(s) |
1. Adverse Events (AEs) 2. Discontinuations
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Pharmacokinetic and Safety Study |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
Colombia |
Ukraine |
Australia |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 3 |