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

NCT01271998 | Completed Phase 1

• 2 other identifiers: 1986-027TR701-119
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Infection

Keywords

antibiotic; healthy subjects; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic parameters from plasma.

  Pharmacokinetic parameters compared with baseline measurements.

  Day 3

Study Arms (1)

healthy volunteer

EXPERIMENTAL

healthy volunteers

Drug: TR-701 FA

Interventions

TR-701 FA DRUG

200 mg, oral, once daily for 3 days.

healthy volunteer

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead

Study Sites (1)

Trius Investigator Site 001

Hartford, Connecticut, 06102, United States

Location

Related Publications (1)

• 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.

  PMID: 22330925 RESULT

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• David Nicolau, PharmD

  Center for Anti-Infective Research and Development

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: January 7, 2011
• Study Start: December 8, 2010
• Primary Completion: January 3, 2011
• Study Completion: January 3, 2011
• Last Updated: November 15, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)