Expired Study
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Madison, Wisconsin 53704


Purpose:

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single rising oral doses and multiple oral doses of TR-701


Study summary:

This is an evaluation of TR-701 in a double-blind, placebo-controlled, randomized, single (Part A) and multiple (Part B) ascending dose safety, tolerance, and PK when administered as a capsule in normal, healthy adult volunteers. The study will be sequential between Part A and Part B (i.e., not staggered or leap frogged), with slight overlap between last cohort in Part A and first cohort in Part B.


Criteria:

Inclusion Criteria: - in good health - body mass index of 20 to 29.9 kg/m2 - female subjects must be either postmenopausal for at least 1 year, surgically sterile, abstinent, or agree to use an effective method of birth control Exclusion Criteria: - history or clinical manifestations of any clinically significant disorder - history of hypersensitivity or allergies to any drug compound - history of stomach or intestinal surgery or resection - history of alcoholism or drug addiction within 1 year - use of any tobacco-containing or nicotine-containing products within 6 months - use of any other medications - use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages; or foods or beverages with high levels of tyramine - pregnancy, lactation, or breastfeeding


NCT ID:

NCT00671814


Primary Contact:

Principal Investigator
John Bohn, MD
Covance Clinical Research Unit


Backup Contact:

N/A


Location Contact:

Madison, Wisconsin 53704
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 19, 2018

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