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Completed

NCT Number: NCT00983255

Ascending Dose Pharmacokinetic (PK) and Absolute Bioavailability (BA)

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.

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Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit

Madison, Wisconsin, 53704, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TR-701 FA for injection, 200 mg/vial

Drug

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 names: Torezolid Phospate

TR-701 FA tablets

Drug

TR-701 FA will be given once orally as a 200 mg tablet in Part C.

Other names: Torezolid Phosphate Tablet

Primary outcomes

  1. Safety Assessments

    Time frame: 10 days

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Industry

Registry information

Official study 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

Acronym: IV/SAD/MAD

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 24, 2009
Registry last updated
May 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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