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
  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 April 21, 2014