Microdialysis and Pharmacokinetic Study of TR-701 - Tabular View

Tracking Information

First Received Date ^ICMJE

April 23, 2008

Last Updated Date

August 6, 2008

Start Date ^ICMJE

April 2008

Estimated Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00666601 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Microdialysis and Pharmacokinetic Study of TR-701

Official Title ^ICMJE

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

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).

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Basic Science, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: TR-700 (active moiety)
Drug: TR-701 (pro-drug)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2008

Estimated Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00666601

Responsible Party

Paul Bien, Senior Director Clinical Operations/Project Management, Trius Therapeutics. Inc.

Study ID Numbers ^ICMJE

TR701-102

Study Sponsor ^ICMJE

Trius Therapeutics, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Harmut Derendorf, PhD

University of Florida

Information Provided By

Trius Therapeutics, Inc.

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP