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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01156077
First Posted: July 2, 2010
Last Update Posted: March 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Trius Therapeutics LLC
  Purpose
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.

Condition Intervention Phase
Bacterial Infection Drug: TR-701 FA Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Trius Therapeutics LLC:

Primary Outcome Measures:
  • Adolescent PK [ Time Frame: 2 days ]
    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.


Enrollment: 20
Actual Study Start Date: June 1, 2010
Study Completion Date: September 1, 2011
Primary Completion Date: September 1, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oral TR-701 FA
Single oral dose of 200 mg TR-701
Drug: TR-701 FA
Oral TR-701 FA 200 mg will be given as a single oral dose
Experimental: IV TR-701 FA
Single IV infusion of 200 mg TR-701 FA
Drug: TR-701 FA
TR-701 FA 200 mg will be given as a single 60 minute IV infusion in 250 cc saline

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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): NCT01156077


Sponsors and Collaborators
Trius Therapeutics LLC
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Trius Therapeutics LLC
ClinicalTrials.gov Identifier: NCT01156077     History of Changes
Other Study ID Numbers: 1986-026
TR701-111 ( Other Identifier: TrisuRX Unique ID )
First Submitted: June 11, 2010
First Posted: July 2, 2010
Last Update Posted: March 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Keywords provided by Trius Therapeutics LLC:
antibiotic
Adolescents receiving antibiotics

Additional relevant MeSH terms:
Bacterial Infections
Torezolid phosphate
Anti-Bacterial Agents
Anti-Infective Agents