Microdialysis and Pharmacokinetic Study of TR-701



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 50
Updated:9/27/2017
Start Date:April 4, 2008
End Date:August 12, 2008

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An Open Label, Single Dose, Microdialysis and Pharmacokinetic Study of TR-701 in Normal Healthy Adults

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).

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
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Gainesville, Florida 32604
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Gainesville, FL
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