Status:
COMPLETED
Single and Multiple Ascending Dose Pharmacokinetic Study of TR701 in Healthy Adults
Lead Sponsor:
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
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
Detailed Description
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 norm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 6 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00671814
Start Date
January 6 2008
End Date
June 6 2008
Last Update
August 31 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Covance Clinical Research Unit
Madison, Wisconsin, United States, 53704