Microdialysis and Pharmacokinetic Study of TR-701

Study Overview
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Brief Summary
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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

Detailed Description
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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).

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: TR-700 (active moiety)
* Drug: TR-701 (pro-drug)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilot study<br>3 subjects, open lable, microdialysis single dose. | Drug: TR-700 (active moiety)<br>* 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).<br>|
| Experimental: Main Study<br>12 subjects, open label, single dose of 600 mg. | Drug: TR-701 (pro-drug)<br>* Each subject enrolled in the Main study will receive a single oral dose of 600mg TR-701<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subcutaneous tissue concentrations of TR-700 |  | Single day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microdialysis, Antibiotic, Healthy subjects