Microdialysis and Pharmacokinetic Study of TR-701

NCT00666601 | Completed Phase 1

• 2 other identifiers: 1986-022TR701-102
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to measure the penetration of TR-700 into subcutaneous adipose tissue and skeletal muscle after a single oral dose of 600 mg TR-701

Conditions

Healthy

Keywords

Microdialysis; Antibiotic; Healthy subjects

Outcome Measures

Primary Outcomes (1)

• Subcutaneous tissue concentrations of TR-700

  Single day

Study Arms (2)

Pilot study

EXPERIMENTAL

3 subjects, open lable, microdialysis single dose.

Drug: TR-700 (active moiety)

Main Study

EXPERIMENTAL

12 subjects, open label, single dose of 600 mg.

Drug: TR-701 (pro-drug)

Interventions

TR-700 (active moiety) DRUG

A TR-700 solution will be locally administered via a microdialysis probe into the skeletal muscle and subcutanous tissue (just under the skin) at a concentration of approximately 2 µg/mL at a flow rate of 1.5 µL/min for 60 minutes for a total maximum dose of 0.36 µg (0.18 µg per probe).

Pilot study

TR-701 (pro-drug) DRUG

Each subject enrolled in the Main study will receive a single oral dose of 600mg TR-701

Main Study

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index of 20 to 29 kg/m2
• Agree not to consume any products containing tobacco, alcohol, quinine, grapefruit, caffeine, or high levels of tyramine
• Agree not to use any other medication
• Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control

You may not qualify if:

• History of gastric or duodenal ulcer within 1 year before enrollment
• Has known or suspected hypersensitivity or intolerance to heparin, if an indwelling cannula (e.g., heparin lock) is used
• Recent febrile illness (less than 72 hours before the first intake of study medication).
• Significant blood loss (300 mL) or donation of blood within the 60 days before the Screening visit
• Women who are pregnant or breast-feeding

Sponsors & Collaborators

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

Study Sites (1)

General Clinical Research Center

Gainesville, Florida, 32604, United States

Location

Related Publications (1)

• Sahre M, Sabarinath S, Grant M, Seubert C, Deanda C, Prokocimer P, Derendorf H. Skin and soft tissue concentrations of tedizolid (formerly torezolid), a novel oxazolidinone, following a single oral dose in healthy volunteers. Int J Antimicrob Agents. 2012 Jul;40(1):51-4. doi: 10.1016/j.ijantimicag.2012.03.006. Epub 2012 May 13.

  PMID: 22584101 RESULT

MeSH Terms

Interventions

tedizolid; tedizolid phosphate; Prodrugs

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Harmut Derendorf, PhD

  University of Florida

  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: April 23, 2008
• First Posted: April 25, 2008
• Study Start: April 4, 2008
• Primary Completion: August 12, 2008
• Study Completion: August 12, 2008
• Last Updated: November 15, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)