Single and Multiple Ascending Dose Pharmacokinetic Study of TR701 in Healthy Adults



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 50
Updated:9/1/2017
Start Date:January 6, 2008
End Date:June 6, 2008

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Trial Summary
Trial Overview
Inclusion Criteria

A Double-Blind, Placebo and Active Controlled, Single and Multiple Rising Dose, Safety, Tolerance, and Pharmacokinetic Study of TR-701 in Normal Healthy Adults

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

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.

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
We found this trial at
1
site
Covance Clinical Research Unit
Madison, Wisconsin 53718
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mi
from
Madison, WI
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