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OpenTrials
Completed

NCT Number: NCT01271998

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

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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Key information

Conditions

Bacterial Infection Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Trius Investigator Site 001

Hartford, Connecticut, 06102, United States

About this study

No applicable.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TR-701 FA

Drug

200 mg, oral, once daily for 3 days.

Primary outcomes

  1. Pharmacokinetic parameters from plasma.

    Time frame: Day 3

    Pharmacokinetic parameters compared with baseline measurements.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 7, 2011
Registry last updated
Nov 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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