Gram-Positive Infections Clinical Trial
Official title:
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
| Verified date | April 2023 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 47 |
| Est. completion date | March 29, 2023 |
| Est. primary completion date | March 18, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Day to 24 Months |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | UMHAT Deva Maria ( Site 2208) | Burgas | |
| Bulgaria | MHAT Dr. Tota Venkova-Pediatrics ( Site 2218) | Gabrovo | |
| Bulgaria | MHAT Sv. Ivan Rilski EOOD ( Site 2201) | Kozloduy | Vratsa |
| Bulgaria | MHAT "Dr. Stamen Iliev" Montana ( Site 2215) | Montana | |
| Bulgaria | MHAT City Clinic Sv. Georgi EOOD ( Site 2202) | Montana | |
| Bulgaria | UMHAT Dr. Georgi Stranski EAD ( Site 2211) | Pleven | |
| Bulgaria | MHAT Rousse-Neonatology ( Site 2213) | Ruse | |
| Bulgaria | Multiprofile Hospital for Active Treatment - Ruse ( Site 2204) | Ruse | |
| Bulgaria | UMHAT Kanev AD ( Site 2209) | Ruse | |
| Bulgaria | Medical Center - 1- Sevlievo EOOD ( Site 2207) | Sevlievo | Gabrovo |
| Bulgaria | MHAT Dr. Ival Seliminski ( Site 2212) | Sliven | |
| Colombia | Clinica de la Costa S.A.S. ( Site 1106) | Barranquilla | Atlantico |
| Colombia | Fundacion Hospital Infantil Universitario de San Jose ( Site 1107) | Bogota | Distrito Capital De Bogota |
| Colombia | Fundacion Valle del Lili ( Site 1102) | Cali | Valle Del Cauca |
| Colombia | Hospital San Vicente Fundacion ( Site 1103) | Medellin | Antioquia |
| Norway | Haukeland Universitetssjukehus ( Site 1602) | Bergen | Hordaland |
| Norway | Akershus Universitetssykehus HF ( Site 1604) | Loerenskog | Akershus |
| Norway | Stavanger Universitetssykehus, Helse Stavanger ( Site 1601) | Stavanger | Rogaland |
| Norway | St. Olavs Hospital. ( Site 1600) | Trondheim | Sor-Trondelag |
| United Kingdom | Alder Hey Childrens NHS Foundation Trust Hospital ( Site 1703) | Liverpool | Lancashire |
| United Kingdom | Royal Victoria Infirmary ( Site 1702) | Newcastle | Newcastle Upon Tyne |
| United Kingdom | Oxford University Hospitals NHS Foundation Trust ( Site 1704) | Oxford | Oxfordshire |
| United Kingdom | University Hospital Southampton NHS Foundation Trust ( Site 1700) | Southampton | Hampshire |
| United States | Our Lady of the Lake Regional Medical Center. ( Site 1004) | Baton Rouge | Louisiana |
| United States | Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 1022) | Chicago | Illinois |
| United States | Arkansas Children's Hospital ( Site 1012) | Little Rock | Arkansas |
| United States | Children's Hospital of Orange County ( Site 1001) | Orange | California |
| United States | Saint Louis Children's Hospital ( Site 1020) | Saint Louis | Missouri |
| United States | Primary Children's Hospital ( Site 1000) | Salt Lake City | Utah |
| United States | Sharp Memorial Hospital ( Site 1021) | San Diego | California |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Bulgaria, Colombia, Norway, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | AUC0-last of tedizolid phosphate | Area under the concentration-time curve from time 0 to time of last quantifiable drug concentration (AUC0-last) of plasma tedizolid phosphate | 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 | |
| Primary | AUC0-inf of tedizolid phosphate | Area under the concentration-time curve from time 0 to infinity (AUC0-inf) of plasma tedizolid phosphate | 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 | |
| Primary | Cmax of tedizolid phosphate | Maximum concentration (Cmax) of plasma tedizolid phosphate | 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 | |
| Primary | Tmax of tedizolid phosphate | Time to reach Cmax (Tmax) of plasma tedizolid phosphate | 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 | |
| Primary | T1/2 of tedizolid phosphate | Apparent terminal half-life (t1/2) of plasma tedizolid phosphate | 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 | |
| Primary | AUC0-last of tedizolid | Area under the concentration-time curve from time 0 to time of last quantifiable drug concentration of plasma tedizolid | 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 | |
| Primary | AUC0-inf of tedizolid | Area under the concentration-time curve from time 0 to infinity of plasma tedizolid | 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 | |
| Primary | Cmax of tedizolid | Maximum concentration of plasma tedizolid | 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 | |
| Primary | Tmax of tedizolid | Time to reach Cmax of plasma tedizolid | 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 | |
| Primary | T1/2 of tedizolid | Apparent terminal half-life of plasma tedizolid | 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 | |
| Secondary | Adverse Events (AEs) | Number of participants with one or more adverse events. | Up to Day 21 | |
| Secondary | Discontinuations | Number of participants who discontinued from study due to an AE | Day 1 |