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A Pharmacokinetic Study of Tedizolid Phosphate in Pediatric Participants With Gram-Positive Infections (MK-1986-014)

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ClinicalTrials.gov Identifier: NCT03217565
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Gram-Positive Infections Drug: IV Tedizolid Phosphate Drug: Oral Suspension Tedizolid Phosphate Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Single-Dose Safety and Pharmacokinetic Study of Oral and IV Tedizolid Phosphate (MK-1986) in Inpatients Under 2 Years Old
Actual Study Start Date : February 6, 2019
Estimated Primary Completion Date : July 5, 2021
Estimated Study Completion Date : July 17, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IV Tedizolid Phosphate
A single dose of 3 mg tedizolid phosphate/kg body weight administered intravenously (IV) as a 0.8 up to 1.6 mg/mL solution
Drug: IV Tedizolid Phosphate
A single dose of tedizolid phosphate administered IV as a 0.8 up to 1.6 mg/mL solution

Experimental: Oral Suspension Tedizolid Phosphate
A single dose of 3 mg tedizolid phosphate/kg body weight administered as an oral suspension
Drug: Oral Suspension Tedizolid Phosphate
A single dose of tedizolid phosphate administered as an oral suspension




Primary Outcome Measures :
  1. AUC0-last of 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 ]
    Area under the concentration-time curve from time 0 to time of last quantifiable drug concentration (AUC0-last) of plasma tedizolid phosphate

  2. AUC0-inf of 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 ]
    Area under the concentration-time curve from time 0 to infinity (AUC0-inf) of plasma tedizolid phosphate

  3. Cmax of 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 ]
    Maximum concentration (Cmax) of plasma tedizolid phosphate

  4. Tmax of 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 ]
    Time to reach Cmax (Tmax) of plasma tedizolid phosphate

  5. T1/2 of 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 ]
    Apparent terminal half-life (t1/2) of plasma tedizolid phosphate

  6. AUC0-last of 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 ]
    Area under the concentration-time curve from time 0 to time of last quantifiable drug concentration of plasma tedizolid

  7. AUC0-inf of 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 ]
    Area under the concentration-time curve from time 0 to infinity of plasma tedizolid

  8. Cmax of 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 ]
    Maximum concentration of plasma tedizolid

  9. Tmax of 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 ]
    Time to reach Cmax of plasma tedizolid

  10. T1/2 of 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 ]
    Apparent terminal half-life of plasma tedizolid


Secondary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: Up to Day 21 ]
    Number of participants with one or more adverse events.

  2. Discontinuations [ Time Frame: Day 1 ]
    Number of participants who discontinued from study due to an AE



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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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; and weighs within >5th percentile and <95th percentile based on age.
  • 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 food and medication by mouth, for those dosed with oral suspension.

Exclusion Criteria:

  • Has a history of seizures, other than febrile seizures, clinically significant cardiac arrhythmia or condition, 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.
  • Has used rifampin within 14 days prior to dosing.
  • Has used or will be using ranitidine, cimetidine or antacids (for those taking 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03217565


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
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United States, Arkansas
Arkansas Children's Hospital ( Site 1012) Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Study Coordinator    501-364-1416      
United States, California
Children's Hospital of Orange County ( Site 1001) Recruiting
Orange, California, United States, 92868
Contact: Study Coordinator    714-509-4791      
Sharp Memorial Hospital ( Site 1021) Recruiting
San Diego, California, United States, 92123
Contact: Study Coordinator    858-939-7424      
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 1022) Recruiting
Chicago, Illinois, United States, 60611
Contact: Study Coordinator    312-227-6285      
United States, Louisiana
Our Lady of the Lake Hospital ( Site 1004) Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Study Coordinator    225-765-5956      
United States, Missouri
Saint Louis Children's Hospital ( Site 1020) Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Study Coordinator    314-747-5128      
United States, Utah
Primary Children's Hospital ( Site 1000) Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Study Coordinator    801-587-6293      
Bulgaria
UMHAT Deva Maria ( Site 2208) Recruiting
Burgas, Bulgaria, 8127
Contact: Study Coordinator    +359884386907      
MHAT Sv. Ivan Rilski EOOD ( Site 2201) Recruiting
Kozloduy, Bulgaria, 3320
Contact: Study Coordinator    +359878690751      
MHAT City Clinic Sv. Georgi EOOD ( Site 2202) Recruiting
Montana, Bulgaria, 3400
Contact: Study Coordinator    +359887397013      
Multiprofile Hospital for Active Treatment - Ruse ( Site 2204) Recruiting
Ruse, Bulgaria, 7002
Contact: Study Coordinator    +359813986      
UMHAT Kanev AD ( Site 2209) Recruiting
Ruse, Bulgaria, 7002
Contact: Study Coordinator    +359888209200      
Medical Center - 1- Sevlievo EOOD ( Site 2207) Recruiting
Sevlievo, Bulgaria, 5400
Contact: Study Coordinator    +359877127333      
Colombia
Fundacion Valle del Lili ( Site 1102) Recruiting
Cali, Valle Del Cauca, Colombia, 760032
Contact: Study Coordinator    +57233190904022      
Hospital San Vicente Fundacion ( Site 1103) Recruiting
Medellin, Colombia, 050010
Contact: Study Coordinator    +573006179956      
Norway
Haukeland Universitetssjukehus ( Site 1602) Recruiting
Bergen, Norway, 5021
Contact: Study Coordinator    +475975720      
Akershus Universitetssykehus HF ( Site 1604) Recruiting
Loerenskog, Norway, 1478
Contact: Study Coordinator    +4741469314      
Stavanger Universitetssykehus, Helse Stavanger ( Site 1601) Recruiting
Stavanger, Norway, 4011
Contact: Study Coordinator    +47515159940      
St. Olavs Hospital. ( Site 1600) Recruiting
Trondheim, Norway, 7006
Contact: Study Coordinator    +4772251241      
United Kingdom
Alder Hey Childrens NHS Foundation Trust Hospital ( Site 1703) Recruiting
Liverpool, United Kingdom, L12 2AP
Contact: Study Coordinator    +441512284811      
Royal Victoria Infirmary ( Site 1702) Recruiting
Newcastle, United Kingdom, NE1 4LP
Contact: Study Coordinator    +441912821527      
Oxford University Hospitals NHS Foundation Trust ( Site 1704) Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Study Coordinator    +441512525570      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03217565     History of Changes
Other Study ID Numbers: 1986-014
2017-000953-38 ( EudraCT Number )
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Tedizolid
Tedizolid phosphate
Oxazolidinones
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action