NCT00983255

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 24, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

4 months

First QC Date

September 22, 2009

Last Update Submit

May 18, 2016

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (1)

  • Safety Assessments

    10 days

Secondary Outcomes (2)

  • To evaluate the pharmacokinetics of TR-701 and its microbiologically active moiety TR-700 after single and multiple IV doses of TR-701 FA

    10 days

  • To determine the absolute bioavailability of oral TR-701 FA following single oral and IV dose administrations in healthy adult subjects

    4 days

Study Arms (4)

SAD/ Part A

EXPERIMENTAL

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

MAD / Part B

EXPERIMENTAL

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

Bioavailability / Part C

EXPERIMENTAL

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/vialDrug: TR-701 FA tablets

Venous Tolerability/ Part D

EXPERIMENTAL

IV infusions of placebo and 200 mg TR-701 FA given daily for 3 days,

Drug: TR-701 FA for injection, 200 mg/vial

Interventions

TR-701 FA for injection, 200 mg/vialDRUG

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

Also known as: Torezolid Phospate
Bioavailability / Part CMAD / Part BSAD/ Part AVenous Tolerability/ Part D
TR-701 FA tabletsDRUG

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

Also known as: Torezolid Phosphate Tablet
Bioavailability / Part C

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

Related Publications (1)

  • Flanagan S, Fang E, Munoz KA, Minassian SL, Prokocimer PG. Single- and multiple-dose pharmacokinetics and absolute bioavailability of tedizolid. Pharmacotherapy. 2014 Sep;34(9):891-900. doi: 10.1002/phar.1458. Epub 2014 Jul 3.

    PMID: 24989138DERIVED

MeSH Terms

Conditions

Bacterial Infections

Interventions

Injectionstedizolid phosphate

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Nicholas Siebers, MD

    Covance Clinical Research Unit, Madison, WI, USA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2009

First Posted

September 24, 2009

Study Start

September 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

May 19, 2016

Record last verified: 2016-05

Locations

US(1)