NCT00666601

Microdialysis and Pharmacokinetic Study of TR-701

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy

Interventions

Type	Name	Description
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).
DRUG	TR-701 (pro-drug)	Each subject enrolled in the Main study will receive a single oral dose of 600mg TR-701

Timeline

• Start date: 2008-04-04
• Primary completion: 2008-08-12
• Completion: 2008-08-12
• First posted: 2008-04-25
• Last updated: 2019-11-15

Locations

1 site across 1 country: United States