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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01271998

Enrollment

Registered

2011-01-07

Start date

2010-12-08

Completion date

2011-01-03

Last updated

2019-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infection

Keywords

antibiotic, healthy subjects, pharmacokinetics

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.

Interventions

DRUGTR-701 FA

200 mg, oral, once daily for 3 days.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetic parameters from plasma.	Day 3	Pharmacokinetic parameters compared with baseline measurements.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026