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Ascending Dose Pharmacokinetic (PK) and Absolute Bioavailability (BA) (IV/SAD/MAD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00983255
First Posted: September 24, 2009
Last Update Posted: May 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Trius Therapeutics LLC
  Purpose
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single rising and multiple rising IV doses of TR-701 FA and to determine the absolute bioavailability of oral TR-701 FA following single oral and IV dose administrations in healthy adult subjects.

Condition Intervention Phase
Bacterial Infections Drug: TR-701 FA for injection, 200 mg/vial Drug: TR-701 FA tablets Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Double-Blind, Placebo-Controlled, Single & Multiple Ascending Dose, Safety, Tolerability, & PK Study of an IV Form of TR-701 Free Acid & an Open-Label, Crossover Absolute BA Determination of a TR-701 FA Tablet in Normal Healthy Adults

Resource links provided by NLM:


Further study details as provided by Trius Therapeutics LLC:

Primary Outcome Measures:
  • Safety Assessments [ Time Frame: 10 days ]

Secondary Outcome Measures:
  • To evaluate the pharmacokinetics of TR-701 and its microbiologically active moiety TR-700 after single and multiple IV doses of TR-701 FA [ Time Frame: 10 days ]
  • To determine the absolute bioavailability of oral TR-701 FA following single oral and IV dose administrations in healthy adult subjects [ Time Frame: 4 days ]

Enrollment: 90
Study Start Date: September 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAD/ Part A
Single IV infusions of placebo or TR-701 FA given at 50, 100, 200, and 400 mg.
Drug: TR-701 FA for injection, 200 mg/vial
TR-701 FA for injection will be given as a single infusion at doses of 50 mg, 100 mg, 200 mg, and 400 mg in SAD/Part A (Pilot and Cohorts 1 to 3). TR-701 FA for injection will be given as once daily infusions at doses of 200 mg and 400 mg for 7 days in MAD/Part B (Cohorts 4 & 5). TR-701 FA for injection will be given once as a 200 mg IV infusion in BA/Part C (Cohort 6). TR-701 FA 200 mg will be given daily for 3 days in Venous Tolerability/Part D
Other Name: Torezolid Phospate
Experimental: MAD / Part B
Multiple IV infusion of placebo or TR-701 FA given daily for 7 days at 200 and 400 mg.
Drug: TR-701 FA for injection, 200 mg/vial
TR-701 FA for injection will be given as a single infusion at doses of 50 mg, 100 mg, 200 mg, and 400 mg in SAD/Part A (Pilot and Cohorts 1 to 3). TR-701 FA for injection will be given as once daily infusions at doses of 200 mg and 400 mg for 7 days in MAD/Part B (Cohorts 4 & 5). TR-701 FA for injection will be given once as a 200 mg IV infusion in BA/Part C (Cohort 6). TR-701 FA 200 mg will be given daily for 3 days in Venous Tolerability/Part D
Other Name: Torezolid Phospate
Experimental: Bioavailability / Part C
TR-701 FA tablet given once orally as a 200 mg tablet or TR-701 FA for injection given once as a 200 mg IV infusion.
Drug: TR-701 FA for injection, 200 mg/vial
TR-701 FA for injection will be given as a single infusion at doses of 50 mg, 100 mg, 200 mg, and 400 mg in SAD/Part A (Pilot and Cohorts 1 to 3). TR-701 FA for injection will be given as once daily infusions at doses of 200 mg and 400 mg for 7 days in MAD/Part B (Cohorts 4 & 5). TR-701 FA for injection will be given once as a 200 mg IV infusion in BA/Part C (Cohort 6). TR-701 FA 200 mg will be given daily for 3 days in Venous Tolerability/Part D
Other Name: Torezolid Phospate
Drug: TR-701 FA tablets
TR-701 FA will be given once orally as a 200 mg tablet in Part C.
Other Name: Torezolid Phosphate Tablet
Experimental: Venous Tolerability/ Part D
IV infusions of placebo and 200 mg TR-701 FA given daily for 3 days,
Drug: TR-701 FA for injection, 200 mg/vial
TR-701 FA for injection will be given as a single infusion at doses of 50 mg, 100 mg, 200 mg, and 400 mg in SAD/Part A (Pilot and Cohorts 1 to 3). TR-701 FA for injection will be given as once daily infusions at doses of 200 mg and 400 mg for 7 days in MAD/Part B (Cohorts 4 & 5). TR-701 FA for injection will be given once as a 200 mg IV infusion in BA/Part C (Cohort 6). TR-701 FA 200 mg will be given daily for 3 days in Venous Tolerability/Part D
Other Name: Torezolid Phospate

Detailed Description:

SAD/Part A.

  • All subjects in the Pilot Cohort will receive a single infusion of 50 mg TR-701 FA for injection in 250 cc of saline over 180 minutes.
  • Subjects in Cohort 1 will be randomized to receive a single infusion of placebo or 100 mg of TR-701 FA for injection in 250 or 500 cc of saline over 60 or 120 minutes.
  • Subjects in Cohort 2 will be randomized to receive a single infusion of placebo or 200 mg of TR-701 FA for injection in 250 or 500 cc of saline over 60 or 120 minutes.
  • Subjects in Cohort 3 will be randomized to receive a single infusion of placebo or 400 mg of TR-701 FA for injection in 250 or 500 cc of saline over 60 or 120 minutes.

MAD/Part B

  • Subjects in Cohort 4 will be randomized to receive once daily infusions of placebo or 200 mg of TR-701 FA for injection in 250 cc of saline over 60 minutes for 7 days.
  • Subjects in Cohort 5 will be randomized to receive once daily infusions of placebo or 300 mg of TR-701 FA for injection in 250 cc of saline over 60 minutes for 7 days.

BA/Part C

  • Subjects in Cohort 6 will receive a single 60 minute infusion of 200 mg TR-701 FA for injection in 250 cc of saline and a singe oral dose of 200 mg TR-701 FA tablet in an open-label crossover design.

Venous Tolerability/Part D

- Subjects in Cohort 8 will receive once daily 60 minute infusions of 200 mg TR-701 FA for injection in 250 cc of saline for 3 days and once daily placebo infusions for 3 daysin a blinded crossover design.

  Eligibility

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • in good health
  • body mass index of 20 to 29.9 kg/m2
  • female subjects must be post menopausal for at least 1 year, surgically sterile, abstinent or agree to use an effective method of birth control

Exclusion Criteria:

  • history or clinical manifestation of any clinically significant disorder
  • history of hypersensitivity to any drug compound
  • history of stomach or intestinal surgery or resection
  • history of infections of unexplained frequency or severity
  • history of alcoholism or drug addiction within 1 year
  • use of any tobacco- or nicotine-containing products within 6 months
  • use of alcohol-, grapefruit-, caffeine-, or high tyramine-containing foods or beverages
  • use of any other medications
  • pregnancy, lactation, or breastfeeding
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00983255


Locations
United States, Wisconsin
Covance Clinical Research Unit
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Trius Therapeutics LLC
Investigators
Principal Investigator: Nicholas Siebers, MD Covance Clinical Research Unit, Madison, WI, USA
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Trius Therapeutics LLC
ClinicalTrials.gov Identifier: NCT00983255     History of Changes
Other Study ID Numbers: 1986-008
TR701-107 ( Other Identifier: TriusRX Unique ID )
First Submitted: September 22, 2009
First Posted: September 24, 2009
Last Update Posted: May 19, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Bacterial Infections
Torezolid phosphate
Torezolid
Anti-Bacterial Agents
Anti-Infective Agents