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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Trius Therapeutics, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 September 14, 2014