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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-08

Study Completion Date

2011-01-03

Brief Summary

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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.

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Detailed Description

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No applicable.

Conditions

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Bacterial Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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healthy volunteer

healthy volunteers

Group Type EXPERIMENTAL

TR-701 FA

Intervention Type DRUG

200 mg, oral, once daily for 3 days.

Interventions

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TR-701 FA

200 mg, oral, once daily for 3 days.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes