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

Primary Purpose

Bacterial Infection

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

TR-701 FA

About this trial

This is an interventional basic science trial for Bacterial Infection focused on measuring antibiotic, healthy subjects, pharmacokinetics

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Trius Investigator Site 001

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

healthy volunteer

Arm Description

healthy volunteers

Outcomes

Primary Outcome Measures

Pharmacokinetic parameters from plasma.

Pharmacokinetic parameters compared with baseline measurements.

Secondary Outcome Measures

Full Information

NCT ID

NCT01271998

First Posted

December 7, 2010

Last Updated

November 13, 2019

Sponsor

Trius Therapeutics LLC

1. Study Identification

Unique Protocol Identification Number

NCT01271998

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

December 8, 2010 (Actual)

Primary Completion Date

January 3, 2011 (Actual)

Study Completion Date

January 3, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Trius Therapeutics LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

No applicable.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bacterial Infection

Keywords

antibiotic, healthy subjects, pharmacokinetics

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

healthy volunteer

Arm Type

Experimental

Arm Description

healthy volunteers

Intervention Type

Drug

Intervention Name(s)

TR-701 FA

Intervention Description

200 mg, oral, once daily for 3 days.

Primary Outcome Measure Information:

Title

Pharmacokinetic parameters from plasma.

Description

Pharmacokinetic parameters compared with baseline measurements.

Time Frame

Day 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Nicolau, PharmD

Organizational Affiliation

Center for Anti-Infective Research and Development

Official's Role

Principal Investigator

Facility Information:

Facility Name

Trius Investigator Site 001

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06102

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

IPD Sharing URL

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

Citations:

PubMed Identifier

22330925

Citation

Housman ST, Pope JS, Russomanno J, Salerno E, Shore E, Kuti JL, Nicolau DP. Pulmonary disposition of tedizolid following administration of once-daily oral 200-milligram tedizolid phosphate in healthy adult volunteers. Antimicrob Agents Chemother. 2012 May;56(5):2627-34. doi: 10.1128/AAC.05354-11. Epub 2012 Feb 13.

Results Reference

result

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

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