Microdialysis and Pharmacokinetic Study of TR-701
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
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||An Open Label, Single Dose, Microdialysis and Pharmacokinetic Study of TR-701 in Normal Healthy Adults|
- Subcutaneous tissue concentrations of TR-700 [ Time Frame: Single day ] [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Study Completion Date:||March 2009|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Experimental: Pilot study
3 subjects, open lable, microdialysis single dose.
Drug: TR-700 (active moiety)
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).
Experimental: Main Study
12 subjects, open label, single dose of 600 mg.
Drug: TR-701 (pro-drug)
Each subject enrolled in the Main study will receive a single oral dose of 600mg TR-701
This study will be conducted in two parts: a Pilot Study and a Main Study. The Pilot Study will be conducted to assess recovery of exogenously administered TR-700 (microbiologically active moiety) via microdialysis. In the Main Study, pharmacokinetics of TR-700 will be determined in both soft tissues (via microdialysis) and plasma after a single oral dose of 600 mg TR-701 (prodrug).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666601
|United States, Florida|
|General Clinical Research Center|
|Gainesville, Florida, United States, 32604|
|Principal Investigator:||Harmut Derendorf, PhD||University of Florida|