Pharmacokinetics, Safety, and Tolerability of TR-701 Free... | NCT01496677

Studies
Pharmacokinetics, Safety, and Tolerability of TR-701 Free Acid (FA) in Elderly Subjects

NCT01496677

Sponsor

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

Status

Completed

Last Update Posted

Oct 6, 2017Actual

Enrollment

28Actual

Phase

Phase 1

Conditions

Healthy Subjects

Interventions

TR-701 FA 200 mg
TR-701 FA 200 mg

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
TR701-109	Other Identifier	TriusRX Unique ID

Status Module

Record Verification Date

Oct 2017

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

Jan 17, 2012Actual

Primary Completion Date

Feb 28, 2012Actual

Completion Date

Feb 28, 2012Actual

First Submitted Date

Dec 19, 2011

First Submission Date that Met QC Criteria

Dec 20, 2011

First Posted Date

Dec 21, 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

Oct 4, 2017

Last Update Posted Date

Oct 6, 2017Actual

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

To compare the pharmacokinetic (PK) profile of TR-700 in elderly subjects versus younger control subjects

Detailed Description

This is an open-label Phase 1 study of a single oral tablet of TR-701 FA 200 mg to compare the TR-700 PK profile in elderly subjects (age 65 years and older, with at least 5 subjects 75 years old or older) and younger control subjects (age 18 to 45 years).

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

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Elderly subjects (65 or older)	Experimental		Drug: TR-701 FA 200 mg
Younger adults (18-45 years old)	Experimental		Drug: TR-701 FA 200 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TR-701 FA 200 mg	Drug	Single oral tablet of TR-701 FA to elderly subjects	Elderly subjects (65 or older)

Measure	Description	Time Frame
Compare PK profile of TR-700 FA in elderly subjects versus younger control subjects		28 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female subjects in the following groups: An elderly subject at least 65 years of age. At least 5 subjects must be at least 75 years of age OR A matched-control subject between 18 and 45 years of age, inclusive
BMI ≥18.0 kg/m2 and ≤35.0 kg/m2

Elderly Group

Medical history, physical examination, and laboratory results consistent with stable health (as determined by the Investigator)

Control Group

Medically stable with no clinically significant abnormalities

Exclusion Criteria:

Significant, uncontrolled, or life-threatening condition or organ or system condition or disease (eg, impaired cognitive status, respiratory insufficiency, advanced malnutrition)
Positive hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibody test result
Previous inclusion in a TR-701 FA or TR-701 clinical study
ECG finding of QTc interval >500 msec, or other clinically significant ECG abnormality at Screening
Female subjects whom are pregnant, lactating or breastfeeding

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Philippe G Prokocimer, MD	Trius Therapeutics	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Trius Investigator Site 001		Daytona Beach	Florida	32117	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29319932	Derived	Flanagan SD, Minassian SL, Prokocimer P. Pharmacokinetics, Safety, and Tolerability of Tedizolid Phosphate in Elderly Subjects. Clin Pharmacol Drug Dev. 2018 Sep;7(7):788-794. doi: 10.1002/cpdd.426. Epub 2018 Jan 10.