Microdialysis and Pharmacokinetic Study of TR-701 - Full Text View

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: TR-700 (active moiety) Drug: TR-701 (pro-drug)	Phase I

ChemIDplus related topics:

Proline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

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

Further study details as provided by Trius Therapeutics, Inc.:

Primary Outcome Measures:

Subcutaneous tissue concentrations of TR-700 [ Time Frame: Single day ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	April 2008
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

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).

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666601

Locations


United States, Florida
	General Clinical Research Center
	Gainesville, Florida, United States, 32604

Sponsors and Collaborators

Trius Therapeutics, Inc.

Investigators


Principal Investigator:	Harmut Derendorf, PhD	University of Florida

More Information

Responsible Party:	Trius Therapeutics. Inc. ( Paul Bien, Senior Director Clinical Operations/Project Management )
Study ID Numbers:	TR701-102
First Received:	April 23, 2008
Last Updated:	August 6, 2008
ClinicalTrials.gov Identifier:	NCT00666601
Health Authority:	United States: Food and Drug Administration

Keywords provided by Trius Therapeutics, Inc.:

Microdialysis

Antibiotic

Healthy subjects

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	Trius Therapeutics, Inc.
Information provided by:	Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00666601