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Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg

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ClinicalTrials.gov Identifier: NCT01271998
Recruitment Status : Completed
First Posted : January 7, 2011
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Trius Therapeutics LLC

Brief Summary:
The primary purpose of this study is to determine the steady-state plasma pharmacokinetics (PK) and properties of TR-700 into the pulmonary epithelial lining fluid (ELF) and alveolar macrophages (AM) of healthy volunteers.

Condition or disease Intervention/treatment Phase
Bacterial Infection Drug: TR-701 FA Phase 1

Detailed Description:
No applicable.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg TR-701 Free Acid in Healthy Volunteers
Actual Study Start Date : December 8, 2010
Actual Primary Completion Date : January 3, 2011
Actual Study Completion Date : January 3, 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: healthy volunteer
healthy volunteers
Drug: TR-701 FA
200 mg, oral, once daily for 3 days.



Primary Outcome Measures :
  1. Pharmacokinetic parameters from plasma. [ Time Frame: Day 3 ]
    Pharmacokinetic parameters compared with baseline measurements.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males and females, between 18 and 55 years of age, inclusive
  • Females must be nonpregnant, nonlactating, and either postmenopausal or surgically sterile or practicing an effective method of birth control
  • Males must be surgically sterile, abstinent, or practicing an effective method of birth control
  • BMI between 20 and 34.9 kg/m2, inclusive

Exclusion Criteria:

  • Allergy to lidocaine, midazolam, or other anesthetics/sedatives of similar classes
  • Physician-diagnosed migraine headaches within 3 years
  • Previous enrollment in a TR-701 or TR-701 FA trial

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): NCT01271998


Locations
United States, Connecticut
Trius Investigator Site 001
Hartford, Connecticut, United States, 06102
Sponsors and Collaborators
Trius Therapeutics LLC
Investigators
Principal Investigator: David Nicolau, PharmD Center for Anti-Infective Research and Development

Responsible Party: Trius Therapeutics LLC
ClinicalTrials.gov Identifier: NCT01271998     History of Changes
Other Study ID Numbers: 1986-027
TR701-119 ( Other Identifier: TriusRX Unique ID )
First Posted: January 7, 2011    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017

Keywords provided by Trius Therapeutics LLC:
antibiotic
healthy subjects
pharmacokinetics

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