Microdialysis and Pharmacokinetic Study of TR-701

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT00666601

Run by

Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

People needed

15

Starts

2008-04-04

Expected to finish

2008-08-12

Last updated by the study team

2019-11-15

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• General Clinical Research Center — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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