Back to resultsA Pharmacokinetic Study of Tedizolid Phosphate in Pediatric Participants With Gram-Positive Infections (MK-1986-014)
Primary Purpose
Gram-Positive Infections
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
IV Tedizolid Phosphate
Oral Suspension Tedizolid Phosphate
Sponsored by
About this trial
This is an interventional treatment trial for Gram-Positive Infections
Eligibility Criteria
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.
Sites / Locations
- Arkansas Children's Hospital ( Site 1012)
- Children's Hospital of Orange County ( Site 1001)
- Sharp Memorial Hospital ( Site 1021)
- Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 1022)
- Our Lady of the Lake Regional Medical Center. ( Site 1004)
- Saint Louis Children's Hospital ( Site 1020)
- Primary Children's Hospital ( Site 1000)
- Medical Center - 1- Sevlievo EOOD ( Site 2207)
- MHAT Sv. Ivan Rilski EOOD ( Site 2201)
- UMHAT Deva Maria ( Site 2208)
- MHAT Dr. Tota Venkova-Pediatrics ( Site 2218)
- MHAT "Dr. Stamen Iliev" Montana ( Site 2215)
- MHAT City Clinic Sv. Georgi EOOD ( Site 2202)
- UMHAT Dr. Georgi Stranski EAD ( Site 2211)
- MHAT Rousse-Neonatology ( Site 2213)
- Multiprofile Hospital for Active Treatment - Ruse ( Site 2204)
- UMHAT Kanev AD ( Site 2209)
- MHAT Dr. Ival Seliminski ( Site 2212)
- Hospital San Vicente Fundacion ( Site 1103)
- Clinica de la Costa S.A.S. ( Site 1106)
- Fundacion Hospital Infantil Universitario de San Jose ( Site 1107)
- Fundacion Valle del Lili ( Site 1102)
- Akershus Universitetssykehus HF ( Site 1604)
- Haukeland Universitetssjukehus ( Site 1602)
- Stavanger Universitetssykehus, Helse Stavanger ( Site 1601)
- St. Olavs Hospital. ( Site 1600)
- University Hospital Southampton NHS Foundation Trust ( Site 1700)
- Alder Hey Childrens NHS Foundation Trust Hospital ( Site 1703)
- Royal Victoria Infirmary ( Site 1702)
- Oxford University Hospitals NHS Foundation Trust ( Site 1704)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
IV Tedizolid Phosphate
Oral Suspension Tedizolid Phosphate
Arm Description
A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered intravenously (IV). For body weight <10 kg: 3 mg/kg; for body weight 10 to <30 kg: 2.5 mg/kg.
A single dose of tedizolid phosphate administered as an oral suspension. For body weight <10 kg: 3 mg/kg; for body weight 10 to <30 kg: 2.5 mg/kg.
Outcomes
Primary Outcome Measures
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
AUC0-inf of tedizolid phosphate
Area under the concentration-time curve from time 0 to infinity (AUC0-inf) of plasma tedizolid phosphate
Cmax of tedizolid phosphate
Maximum concentration (Cmax) of plasma tedizolid phosphate
Tmax of tedizolid phosphate
Time to reach Cmax (Tmax) of plasma tedizolid phosphate
T1/2 of tedizolid phosphate
Apparent terminal half-life (t1/2) of plasma tedizolid phosphate
AUC0-last of tedizolid
Area under the concentration-time curve from time 0 to time of last quantifiable drug concentration of plasma tedizolid
AUC0-inf of tedizolid
Area under the concentration-time curve from time 0 to infinity of plasma tedizolid
Cmax of tedizolid
Maximum concentration of plasma tedizolid
Tmax of tedizolid
Time to reach Cmax of plasma tedizolid
T1/2 of tedizolid
Apparent terminal half-life of plasma tedizolid
Secondary Outcome Measures
Adverse Events (AEs)
Number of participants with one or more adverse events.
Discontinuations
Number of participants who discontinued from study due to an AE
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03217565
Brief Title
A Pharmacokinetic Study of Tedizolid Phosphate in Pediatric Participants With Gram-Positive Infections (MK-1986-014)
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
March 18, 2023 (Actual)
Study Completion Date
March 29, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gram-Positive Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IV Tedizolid Phosphate
Arm Type
Experimental
Arm Description
A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered intravenously (IV). For body weight <10 kg: 3 mg/kg; for body weight 10 to <30 kg: 2.5 mg/kg.
Arm Title
Oral Suspension Tedizolid Phosphate
Arm Type
Experimental
Arm Description
A single dose of tedizolid phosphate administered as an oral suspension. For body weight <10 kg: 3 mg/kg; for body weight 10 to <30 kg: 2.5 mg/kg.
Intervention Type
Drug
Intervention Name(s)
IV Tedizolid Phosphate
Intervention Description
A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered IV.
Intervention Type
Drug
Intervention Name(s)
Oral Suspension Tedizolid Phosphate
Intervention Description
A single dose of tedizolid phosphate administered as an oral suspension.
Primary Outcome Measure Information:
Title
AUC0-last of tedizolid phosphate
Description
Area under the concentration-time curve from time 0 to time of last quantifiable drug concentration (AUC0-last) of plasma tedizolid phosphate
Time Frame
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
Title
AUC0-inf of tedizolid phosphate
Description
Area under the concentration-time curve from time 0 to infinity (AUC0-inf) of plasma tedizolid phosphate
Time Frame
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
Title
Cmax of tedizolid phosphate
Description
Maximum concentration (Cmax) of plasma tedizolid phosphate
Time Frame
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
Title
Tmax of tedizolid phosphate
Description
Time to reach Cmax (Tmax) of plasma tedizolid phosphate
Time Frame
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
Title
T1/2 of tedizolid phosphate
Description
Apparent terminal half-life (t1/2) of plasma tedizolid phosphate
Time Frame
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
Title
AUC0-last of tedizolid
Description
Area under the concentration-time curve from time 0 to time of last quantifiable drug concentration of plasma tedizolid
Time Frame
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
Title
AUC0-inf of tedizolid
Description
Area under the concentration-time curve from time 0 to infinity of plasma tedizolid
Time Frame
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
Title
Cmax of tedizolid
Description
Maximum concentration of plasma tedizolid
Time Frame
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
Title
Tmax of tedizolid
Description
Time to reach Cmax of plasma tedizolid
Time Frame
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
Title
T1/2 of tedizolid
Description
Apparent terminal half-life of plasma tedizolid
Time Frame
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 Outcome Measure Information:
Title
Adverse Events (AEs)
Description
Number of participants with one or more adverse events.
Time Frame
Up to Day 21
Title
Discontinuations
Description
Number of participants who discontinued from study due to an AE
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Arkansas Children's Hospital ( Site 1012)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Children's Hospital of Orange County ( Site 1001)
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Sharp Memorial Hospital ( Site 1021)
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 1022)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Our Lady of the Lake Regional Medical Center. ( Site 1004)
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Saint Louis Children's Hospital ( Site 1020)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Primary Children's Hospital ( Site 1000)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Medical Center - 1- Sevlievo EOOD ( Site 2207)
City
Sevlievo
State/Province
Gabrovo
ZIP/Postal Code
5400
Country
Bulgaria
Facility Name
MHAT Sv. Ivan Rilski EOOD ( Site 2201)
City
Kozloduy
State/Province
Vratsa
ZIP/Postal Code
3320
Country
Bulgaria
Facility Name
UMHAT Deva Maria ( Site 2208)
City
Burgas
ZIP/Postal Code
8127
Country
Bulgaria
Facility Name
MHAT Dr. Tota Venkova-Pediatrics ( Site 2218)
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Facility Name
MHAT "Dr. Stamen Iliev" Montana ( Site 2215)
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Facility Name
MHAT City Clinic Sv. Georgi EOOD ( Site 2202)
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Facility Name
UMHAT Dr. Georgi Stranski EAD ( Site 2211)
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
MHAT Rousse-Neonatology ( Site 2213)
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment - Ruse ( Site 2204)
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
UMHAT Kanev AD ( Site 2209)
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
MHAT Dr. Ival Seliminski ( Site 2212)
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
Hospital San Vicente Fundacion ( Site 1103)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050010
Country
Colombia
Facility Name
Clinica de la Costa S.A.S. ( Site 1106)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Fundacion Hospital Infantil Universitario de San Jose ( Site 1107)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
111221
Country
Colombia
Facility Name
Fundacion Valle del Lili ( Site 1102)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760032
Country
Colombia
Facility Name
Akershus Universitetssykehus HF ( Site 1604)
City
Loerenskog
State/Province
Akershus
ZIP/Postal Code
1478
Country
Norway
Facility Name
Haukeland Universitetssjukehus ( Site 1602)
City
Bergen
State/Province
Hordaland
ZIP/Postal Code
5021
Country
Norway
Facility Name
Stavanger Universitetssykehus, Helse Stavanger ( Site 1601)
City
Stavanger
State/Province
Rogaland
ZIP/Postal Code
4011
Country
Norway
Facility Name
St. Olavs Hospital. ( Site 1600)
City
Trondheim
State/Province
Sor-Trondelag
ZIP/Postal Code
7006
Country
Norway
Facility Name
University Hospital Southampton NHS Foundation Trust ( Site 1700)
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Alder Hey Childrens NHS Foundation Trust Hospital ( Site 1703)
City
Liverpool
State/Province
Lancashire
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Facility Name
Royal Victoria Infirmary ( Site 1702)
City
Newcastle
State/Province
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust ( Site 1704)
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Learn more about this trial
A Pharmacokinetic Study of Tedizolid Phosphate in Pediatric Participants With Gram-Positive Infections (MK-1986-014)
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