Microdialysis and Pharmacokinetic Study of TR-701

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00666601

Enrollment

Registered

2008-04-25

Start date

2008-04-04

Completion date

2008-08-12

Last updated

2019-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Microdialysis, Antibiotic, Healthy subjects

Brief summary

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

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).

Interventions

DRUGTR-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).

DRUGTR-701 (pro-drug)

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Subcutaneous tissue concentrations of TR-700	Single day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026