Microdialysis and Pharmacokinetic Study of TR-701
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 9/27/2017 |
Start Date: | April 4, 2008 |
End Date: | August 12, 2008 |
An Open Label, Single Dose, Microdialysis and Pharmacokinetic Study of TR-701 in Normal Healthy Adults
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
tissue and skeletal muscle after a single oral dose of 600 mg TR-701
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).
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).
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
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