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A Study of Oral and Intravenous (IV) Tedizolid Phosphate in Hospitalized Participants, Ages 2 to <12 Years, With Confirmed or Suspected Bacterial Infection (MK-1986-013)

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ClinicalTrials.gov Identifier: NCT02750761
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This is a study to assess the pharmacokinetics (PK) of tedizolid phosphate and its active metabolite, tedizolid, and the safety of tedizolid phosphate following administration of a single IV (Part A) or oral suspension (Part B) administration to hospitalized participants ages 6 to <12 years (Groups 1 and 3, respectively), and 2 to <6 years (Groups 2 and 4, respectively).

Condition or disease Intervention/treatment Phase
Gram-Positive Bacterial Infections Drug: Tedizolid Phosphate (IV) Drug: Tedizolid Phosphate (oral suspension) Phase 1

Detailed Description:

Part A (IV):

  • Group 1 (Cohort 1 and Cohort 2) (6 to <12 years)
  • Group 2 (Cohort 1 and Cohort 2) (2 to <6 years)

Part B (Oral Suspension):

  • Group 3 (6 to <12 years)
  • Group 4 (2 to <6 years)

In Cohort 1 of Group 1 (IV) participants received a single administration of tedizolid phosphate at 5 mg/kg of total body weight. After all participants in Cohort 1 of Group 1 received study drug, a preliminary analysis of the safety and PK data was performed and results were used to select 4 mg/kg as the appropriate dose for Cohort 2 of Group 1 and Group 3, and to select 6 mg/kg as the starting dose for the younger participants, Cohort 1 of Group 2. After all participants in Cohort 1 of Group 2 receive study drug, another preliminary analysis of the safety and PK data will be performed and results will be used to confirm 6 mg/kg as the appropriate dose for Cohort 2 of Group 2. Similarly, the Group 4 dose will be confirmed after data review of Group 3 results.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Single-Administration Pharmacokinetic and Safety Study of Oral and IV Tedizolid Phosphate in Hospitalized Subjects 2 to <12 Years Old
Actual Study Start Date : May 2, 2016
Actual Primary Completion Date : December 16, 2018
Actual Study Completion Date : December 21, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part A, Group 1: Tedizolid Phosphate (IV)
Single IV infusion of tedizolid phosphate administered to participants 6 to <12 years of age. Cohort 1 will receive 5 mg/kg of total body weight. Cohort 2 will receive 4 mg/kg of total body weight.
Drug: Tedizolid Phosphate (IV)
Other Names:
  • Sivextro
  • TR-701 FA

Experimental: Part A, Group 2: Tedizolid Phosphate (IV)
Single IV infusion of tedizolid phosphate administered to participants 2 to <6 years of age. Cohort 1 and Cohort 2 will receive 6 mg/kg of total body weight with a potential adjustment up to a maximum dose of 200 mg of tedizolid phosphate.
Drug: Tedizolid Phosphate (IV)
Other Names:
  • Sivextro
  • TR-701 FA

Experimental: Part B, Group 3: Tedizolid Phosphate (oral)
Single dose of tedizolid phosphate administered as an oral suspension at 4 mg/kg of total body weight to participants 6 to <12 years of age. Administration of tedizolid phosphate as an oral suspension is to occur within 15-60 minutes following a meal.
Drug: Tedizolid Phosphate (oral suspension)
Other Names:
  • Sivextro
  • TR-701 FA

Experimental: Part B, Group 4: Tedizolid Phosphate (oral)
Single dose of tedizolid phosphate administered as an oral suspension at 6 mg/kg of total body weight with a potential adjustment up to a maximum dose of 200 mg of tedizolid phosphate to participants 2 to <6 years of age. Administration of tedizolid phosphate as an oral suspension is to occur within 15-60 minutes following a meal.
Drug: Tedizolid Phosphate (oral suspension)
Other Names:
  • Sivextro
  • TR-701 FA




Primary Outcome Measures :
  1. Maximum observed drug concentration in plasma (Cmax) of tedizolid phosphate [ Time Frame: Part A: immediately after the end of the 1 hour infusion, and at 1.5, 2, 3, 4, 6, 12, and 24 hours after the start of infusion ]
    Cmax of IV tedizolid phosphate (TZD) and its active metabolite, tedizolid, in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2).

  2. Time to reach peak plasma concentration (tmax) of tedizolid phosphate [ Time Frame: Part A: immediately after the end of the 1 hour infusion, and at 1.5, 2, 3, 4, 6, 12, and 24 hours after the start of infusion ]
    Tmax of IV TZD and its active metabolite, tedizolid, in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2).

  3. Area under the plasma concentration-time curve (AUC) of tedizolid phosphate [ Time Frame: Part A: immediately after the end of the 1 hour infusion, and at 1.5, 2, 3, 4, 6, 12, and 24 hours after the start of infusion ]
    AUC of IV TZD and its active metabolite, tedizolid, in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2).

  4. Terminal elimination half-life (t1/2) of tedizolid phosphate [ Time Frame: Part A: immediately after the end of the 1 hour infusion, and at 1.5, 2, 3, 4, 6, 12, and 24 hours after the start of infusion ]
    T1/2 of IV TZD and its active metabolite, tedizolid, in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2).

  5. Clearance after oral administration (CL/F) of tedizolid phosphate [ Time Frame: Part A: immediately after the end of the 1 hour infusion, and at 1.5, 2, 3, 4, 6, 12, and 24 hours after the start of infusion ]
    CL/F of oral suspension TZD and its active metabolite, tedizolid, in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2).

  6. Clearance after IV administration (CL) of tedizolid phosphate [ Time Frame: Part A: immediately after the end of the 1 hour infusion, and at 1.5, 2, 3, 4, 6, 12, and 24 hours after the start of infusion ]
    CL of IV TZD and its active metabolite, tedizolid, in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2).

  7. Percent bioavailability of tedizolid [ Time Frame: Part B (2 to <6 years): 3, 6, 9, 12, 24, and 48 hours after study drug administration; Part B (6 to <12 years): 1, 2, 3, 4, 6, 8, 12, and 24 hours after study drug administration ]
    Bioavailability will be determined by comparing the area under the concentration time curve (AUC) of an oral dose vs. IV dose of tedizolid phosphate.



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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Receiving prophylaxis for or with a confirmed or suspected infection with Gram-positive bacteria and receiving concurrent antibiotic treatment with Gram-positive antibacterial activity;
  • Weight >5th percentile and <95th percentile based on age;
  • Stable condition as determined from medical history, physical examination, minimally 5-lead ECG, vital signs, and clinical laboratory evaluations;
  • Females must be premenarchal, abstinent, or practicing an effective method of birth control;

Exclusion Criteria:

  • History of seizures, other than febrile seizures, clinical significant cardiac arrhythmia, cystic fibrosis, moderate or severe renal impairment, or any physical condition that could interfere with the study results;
  • Recent (3 month) history or current infection with viral hepatitis or other significant hepatic disease;
  • History of drug allergy or hypersensitivity to oxazolidinones;
  • Pregnant or breast feeding;
  • Significant blood loss within 60 days prior to study start;
  • Any acute or chronic condition that would limit the participant's ability to complete and/or participate in this clinical study.
  • Treatment with investigational medicinal product within 30 days before the infusion/dose of study drug.
  • Oral administration of methotrexate, topotecan, irinotecan or rosuvastatin, during administration of oral study drug. Administration during the follow-up period is allowed, as is administration during treatment with IV study drug.
  • Use of monoamine oxidase inhibitors or serotonergic agents including tricyclic antidepressants, selective serotonin reuptake inhibitors, and serotonin 5 hydroxytryptamine receptor agonists (triptans), meperidine, or buspirone within,14 days prior to study, or planned use while on study.

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): NCT02750761


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: NCT02750761     History of Changes
Other Study ID Numbers: 1986-013
TR701-120 ( Other Identifier: Cubist Protocol Number )
2015-004595-29 ( EudraCT Number )
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 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
Bacterial Infections
Gram-Positive Bacterial Infections
Tedizolid phosphate
Tedizolid
Oxazolidinones
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action