Single and Multiple Ascending Dose Pharmacokinetic Study of TR701 in Healthy Adults (SAD/MAD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00671814
First received: May 1, 2008
Last updated: June 1, 2012
Last verified: October 2011
  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 1

Study Type: Interventional
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
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:


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 ]

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
Experimental: 1
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.
Placebo Comparator: 2
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.
Active Comparator: 3
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.
ClinicalTrials.gov Identifier: NCT00671814     History of Changes
Other Study ID Numbers: TR701-101
Study First Received: May 1, 2008
Last Updated: June 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Trius Therapeutics, Inc.:
antibiotic

Additional relevant MeSH terms:
Linezolid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 20, 2014