Status:
COMPLETED
Microdialysis and Pharmacokinetic Study of TR-701
Lead Sponsor:
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 4 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00666601
Start Date
April 4 2008
End Date
August 12 2008
Last Update
November 15 2019
Active Locations (1)
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1
General Clinical Research Center
Gainesville, Florida, United States, 32604