Microdialysis and Pharmacokinetic Study of TR-701

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-04

Study Completion Date

2008-08-12

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

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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).

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Pilot study

3 subjects, open lable, microdialysis single dose.

Group Type EXPERIMENTAL

TR-700 (active moiety)

Intervention Type 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).

Main Study

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

Group Type EXPERIMENTAL

TR-701 (pro-drug)

Intervention Type DRUG

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

Interventions

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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).

Intervention Type DRUG

TR-701 (pro-drug)

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

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes