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Gainesville, Florida 32604


Purpose:

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


Study summary:

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).


Criteria:

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


NCT ID:

NCT00666601


Primary Contact:

Principal Investigator
Harmut Derendorf, PhD
University of Florida


Backup Contact:

N/A


Location Contact:

Gainesville, Florida 32604
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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