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
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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
15
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).
Each subject enrolled in the Main study will receive a single oral dose of 600mg TR-701
General Clinical Research Center
Gainesville, Florida, United States
Subcutaneous tissue concentrations of TR-700
Time frame: Single day
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