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Pharmacokinetic (PK) Study of Oral and IV TR-701 FA in Adolescent Patients

Primary Purpose

Bacterial Infection

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
TR-701 FA
TR-701 FA
Sponsored by
Trius Therapeutics LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bacterial Infection focused on measuring antibiotic, Adolescents receiving antibiotics

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • males and females, between 12 and 17 years of age, inclusive;
  • receiving prophylaxis for or have a confirmed or suspected infection with Gram positive bacteria and receiving concurrent antibiotic treatment with Gram positive antibacterial activity
  • in stable condition
  • females must be premenarchal, surgically sterile, abstinent, or practicing an effective method of birth control
  • males will either be surgically sterile, abstinent, or practicing an effective method of birth control

Exclusion Criteria:

  • relevant history of seizures, clinically significant cardiac arrhythmia, cystic fibrosis, moderate or severe renal impairment, or any physical condition that could interfere with the interpretation of the study results
  • any acute or chronic condition that, in the opinion of the Investigator, would limit the patient's ability to complete and/or participate in this clinical study
  • physician-diagnosed migraine headaches
  • history of infection with hepatitis or other significant hepatic disease
  • females who are pregnant or breast feeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    oral TR-701 FA

    IV TR-701 FA

    Arm Description

    Single oral dose of 200 mg TR-701

    Single IV infusion of 200 mg TR-701 FA

    Outcomes

    Primary Outcome Measures

    Adolescent PK
    To describe the single-dose pharmacokinetics (PK) of IV and oral TR-701 FA administration in 12 to 17 year old adolescent patients, based on the individual plasma and urine concentration-time data.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 11, 2010
    Last Updated
    December 6, 2018
    Sponsor
    Trius Therapeutics LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01156077
    Brief Title
    Pharmacokinetic (PK) Study of Oral and IV TR-701 FA in Adolescent Patients
    Official Title
    A Phase 1, Open-Label, Multi-Center, Two-Part, Single-Dose, Parallel Design, Safety, Tolerance, and Pharmacokinetic Study of Orally and Intravenously Administered TR-701 FA in 12 to 17 Year Old Adolescent Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2, 2010 (Actual)
    Primary Completion Date
    September 24, 2011 (Actual)
    Study Completion Date
    September 24, 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Trius Therapeutics LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is an open-label, multi-center, two-part, parallel-design study to assess the PK, safety, and tolerability of TR-701 FA and its active metabolite, TR-700, following a single oral dose (Part A) or IV dose (Part B) of TR-701 FA in 12 to 17 year old adolescent patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bacterial Infection
    Keywords
    antibiotic, Adolescents receiving antibiotics

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    oral TR-701 FA
    Arm Type
    Experimental
    Arm Description
    Single oral dose of 200 mg TR-701
    Arm Title
    IV TR-701 FA
    Arm Type
    Experimental
    Arm Description
    Single IV infusion of 200 mg TR-701 FA
    Intervention Type
    Drug
    Intervention Name(s)
    TR-701 FA
    Intervention Description
    Oral TR-701 FA 200 mg will be given as a single oral dose
    Intervention Type
    Drug
    Intervention Name(s)
    TR-701 FA
    Intervention Description
    TR-701 FA 200 mg will be given as a single 60 minute IV infusion in 250 cc saline
    Primary Outcome Measure Information:
    Title
    Adolescent PK
    Description
    To describe the single-dose pharmacokinetics (PK) of IV and oral TR-701 FA administration in 12 to 17 year old adolescent patients, based on the individual plasma and urine concentration-time data.
    Time Frame
    2 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: males and females, between 12 and 17 years of age, inclusive; receiving prophylaxis for or have a confirmed or suspected infection with Gram positive bacteria and receiving concurrent antibiotic treatment with Gram positive antibacterial activity in stable condition females must be premenarchal, surgically sterile, abstinent, or practicing an effective method of birth control males will either be surgically sterile, abstinent, or practicing an effective method of birth control Exclusion Criteria: relevant history of seizures, clinically significant cardiac arrhythmia, cystic fibrosis, moderate or severe renal impairment, or any physical condition that could interfere with the interpretation of the study results any acute or chronic condition that, in the opinion of the Investigator, would limit the patient's ability to complete and/or participate in this clinical study physician-diagnosed migraine headaches history of infection with hepatitis or other significant hepatic disease females who are pregnant or breast feeding
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    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
    Citations:
    PubMed Identifier
    26910588
    Citation
    Bradley JS, Flanagan SD, Arrieta AC, Jacobs R, Capparelli E, Prokocimer P. Pharmacokinetics, Safety and Tolerability of Single Oral or Intravenous Administration of 200 mg Tedizolid Phosphate in Adolescents. Pediatr Infect Dis J. 2016 Jun;35(6):628-33. doi: 10.1097/INF.0000000000001096.
    Results Reference
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    Pharmacokinetic (PK) Study of Oral and IV TR-701 FA in Adolescent Patients

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