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

November 13, 2019 updated by: Trius Therapeutics LLC

Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg TR-701 Free Acid in Healthy Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

No applicable.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Trius Investigator Site 001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: healthy volunteer
healthy volunteers
Drug: TR-701 FA
200 mg, oral, once daily for 3 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameters from plasma.
Time Frame: Day 3
Pharmacokinetic parameters compared with baseline measurements.
Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trius Therapeutics LLC

Investigators

  • Principal Investigator: David Nicolau, PharmD, Center for Anti-Infective Research and Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 8, 2010

Primary Completion (ACTUAL)

January 3, 2011

Study Completion (ACTUAL)

January 3, 2011

Study Registration Dates

First Submitted

December 7, 2010

First Submitted That Met QC Criteria

January 5, 2011

First Posted (ESTIMATE)

January 7, 2011

Study Record Updates

Last Update Posted (ACTUAL)

November 15, 2019

Last Update Submitted That Met QC Criteria

November 13, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1986-027
  • TR701-119 (OTHER: TriusRX Unique ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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