Healthy Subjects Clinical Trial
— SAD/MADOfficial title:
A Double-Blind, Placebo and Active Controlled, Single and Multiple Rising Dose, Safety, Tolerance, and Pharmacokinetic Study of TR-701 in Normal Healthy Adults
Verified date | August 2017 |
Source | Trius Therapeutics LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 80 |
Est. completion date | June 6, 2008 |
Est. primary completion date | June 6, 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Covance Clinical Research Unit | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Trius Therapeutics LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse Event reporting | 21 days | ||
Secondary | The PK rate and extent of urinary excretion of TR-701 and its microbiologically active moiety, TR-700 | 21 days |
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