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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01271998
First received: December 7, 2010
Last updated: September 15, 2011
Last verified: August 2011
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Trius Therapeutics, Inc.:

Primary Outcome Measures:
  • Pharmacokinetic parameters from plasma. [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Pharmacokinetic parameters compared with baseline measurements.


Enrollment: 20
Study Start Date: December 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: healthy volunteer
healthy volunteers
 Drug: TR-701 FA
200 mg, oral, once daily for 3 days.

Detailed Description:

No applicable.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01271998

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

No publications provided

Responsible Party: Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01271998     History of Changes
Other Study ID Numbers: TR701-119
Study First Received: December 7, 2010
Last Updated: September 15, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Trius Therapeutics, Inc.:
antibiotic
healthy subjects
pharmacokinetics

Additional relevant MeSH terms:
Bacterial Infections

ClinicalTrials.gov processed this record on June 18, 2013