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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014