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

Phase 1

Completed

• Conditions: Bacterial Infection
• Interventions: Drug: TR-701 FA

• Registration Number: NCT01271998
• Lead Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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.

Study Timeline

• Study First Submitted: 2010-12-07
• Study Start: 2010-12-08
• Primary Completion: 2011-01-03
• Study Completion: 2011-01-03
• Study First Submitted QC: 2011-01-05
• Study First Posted: 2011-01-07
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-13
• Last Update Posted: 2019-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
healthy volunteer	TR-701 FA	healthy volunteers

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters from plasma.	Day 3	Pharmacokinetic parameters compared with baseline measurements.

Trial Locations

Locations (1)

Trius Investigator Site 001; 🇺🇸 Hartford, Connecticut, United States