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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 21, 2014