DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Trius Therapeutics LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Subjects

Intervention: TR-701 (Drug); linezolid (Drug); placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Trius Therapeutics LLC

Official(s) and/or principal investigator(s):
John Bohn, MD, Principal Investigator, Affiliation: Covance Clinical Research Unit

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

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: Adverse Event reporting

Secondary outcome: The PK rate and extent of urinary excretion of TR-701 and its microbiologically active moiety, TR-700

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 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.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

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

Locations and Contacts

Covance Clinical Research Unit, Madison, Wisconsin 53704, United States
Additional Information

Starting date: January 2008
Last updated: June 1, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017