Single and Multiple Ascending Dose Pharmacokinetic Study of TR701 in Healthy Adults - Full Text View

Sponsor:	Trius Therapeutics, Inc.
Information provided by:	Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00671814

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

Condition	Intervention	Phase
Healthy Subjects	Drug: TR-701 Drug: linezolid Drug: placebo	Phase I

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Pharmacokinetics Study
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

Resource links provided by NLM:

Drug Information available for: Linezolid

U.S. FDA Resources

Further study details as provided by Trius Therapeutics, Inc.:

Primary Outcome Measures:

Adverse Event reporting [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The PK rate and extent of urinary excretion of TR-701 and its microbiologically active moiety, TR-700 [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	January 2008
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Single oral dose of TR-701 given once at 200mg, 400mg, 600mg, 800mg, and 1200mg. Multiple oral doses of TR-701 given once daily for 21 days at 200mg, 300mg and 400mg.	Drug: TR-701 TR-701 will be given as single oral doses in Cohorts 1-5 and as once daily oral doses for 21 days in cohorts 6-8.
2: Placebo Comparator Single oral dose of placebo given in cohorts 1-5. Multiple oral doses of placebo given once daily for 21 days in cohorts 6-8 and twice daily for 21 days in cohort 10.	Drug: placebo Placebo will be given once for cohorts 1-5, once daily for 21 days for cohorts 6-8, and twice daily for 21 days for cohort 10.
3: Active Comparator Oral doses of 600mg linezolid given twice daily for 21 days.	Drug: linezolid Linezolid will be given at 600 mg twice daily for 21 days in cohort 10.

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

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671814

Locations

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

Sponsors and Collaborators

Trius Therapeutics, Inc.

Investigators

Principal Investigator:

John Bohn, MD

Covance Clinical Research Unit

More Information

No publications provided

Responsible Party:	Trius Therapeutics, Inc. ( Paul Bien, Senior Director Clinical Operations/Project Management )
Study ID Numbers:	TR701-101
Study First Received:	May 1, 2008
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00671814 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Trius Therapeutics, Inc.:

antibiotic

Additional relevant MeSH terms:

Protein Synthesis Inhibitors
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Enzyme Inhibitors
Linezolid
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010