Pulmonary Disposition of TR-700 Following Once-Daily Oral... | NCT01271998

Studies
Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg

NCT01271998

Sponsor

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

Status

Completed

Last Update Posted

Nov 15, 2019Actual

Enrollment

20Actual

Phase

Phase 1

Conditions

Bacterial Infection

Interventions

TR-701 FA

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
TR701-119	Other Identifier	TriusRX Unique ID

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 8, 2010Actual

Primary Completion Date

Jan 3, 2011Actual

Completion Date

Jan 3, 2011Actual

First Submitted Date

Dec 7, 2010

First Submission Date that Met QC Criteria

Jan 5, 2011

First Posted Date

Jan 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2019

Last Update Posted Date

Nov 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary purpose of this study is to determine the steady-state plasma pharmacokinetics (PK) and properties of TR-700 into the pulmonary epithelial lining fluid (ELF) and alveolar macrophages (AM) of healthy volunteers.

Detailed Description

No applicable.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
healthy volunteer	Experimental	healthy volunteers	Drug: TR-701 FA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TR-701 FA	Drug	200 mg, oral, once daily for 3 days.	healthy volunteer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetic parameters from plasma.	Pharmacokinetic parameters compared with baseline measurements.	Day 3

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy males and females, between 18 and 55 years of age, inclusive
Females must be nonpregnant, nonlactating, and either postmenopausal or surgically sterile or practicing an effective method of birth control
Males must be surgically sterile, abstinent, or practicing an effective method of birth control
BMI between 20 and 34.9 kg/m2, inclusive

Exclusion Criteria:

Allergy to lidocaine, midazolam, or other anesthetics/sedatives of similar classes
Physician-diagnosed migraine headaches within 3 years
Previous enrollment in a TR-701 or TR-701 FA trial

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Nicolau, PharmD	Center for Anti-Infective Research and Development	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Trius Investigator Site 001		Hartford	Connecticut	06102	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22330925	Result	Housman ST, Pope JS, Russomanno J, Salerno E, Shore E, Kuti JL, Nicolau DP. Pulmonary disposition of tedizolid following administration of once-daily oral 200-milligram tedizolid phosphate in healthy adult volunteers. Antimicrob Agents Chemother. 2012 May;56(5):2627-34. doi: 10.1128/AAC.05354-11. Epub 2012 Feb 13.

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections