Microdialysis and Pharmacokinetic Study of TR-701

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Trius Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT00666601

First received: April 23, 2008

Last updated: October 12, 2011

Last verified: October 2011

History of Changes

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 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
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 ]

Enrollment:	15
Study Start Date:	April 2008
Study Completion Date:	March 2009
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pilot study 3 subjects, open lable, microdialysis single dose.	Drug: 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).
Experimental: Main Study 12 subjects, open label, single dose of 600 mg.	Drug: TR-701 (pro-drug) 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

No publications provided

Responsible Party:	Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00666601 History of Changes
Other Study ID Numbers:	TR701-102
Study First Received:	April 23, 2008
Last Updated:	October 12, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Trius Therapeutics, Inc.:

Microdialysis
Antibiotic
Healthy subjects

ClinicalTrials.gov processed this record on May 23, 2013

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