NCT01496677

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2012

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

First Submitted

Initial submission to the registry

December 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2011

Completed
27 days until next milestone

Study Start

First participant enrolled

January 17, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2012

Completed
Last Updated

October 6, 2017

Status Verified

October 1, 2017

Enrollment Period

1 month

First QC Date

December 19, 2011

Last Update Submit

October 4, 2017

Conditions

Healthy Subjects

Keywords

volunteer

Outcome Measures

Primary Outcomes (1)

  • Compare PK profile of TR-700 FA in elderly subjects versus younger control subjects

    28 days

Study Arms (2)

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

TR-701 FA 200 mgDRUG

Single oral tablet of TR-701 FA to elderly subjects

Elderly subjects (65 or older)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • ECG finding of QTc interval \>500 msec, or other clinically significant ECG abnormality at Screening
  • Female subjects whom are pregnant, lactating or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trius Investigator Site 001

Daytona Beach, Florida, 32117, United States

Location

Related Publications (1)

  • 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.

    PMID: 29319932DERIVED

Study Officials

  • Philippe G Prokocimer, MD

    Trius Therapeutics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2011

First Posted

December 21, 2011

Study Start

January 17, 2012

Primary Completion

February 28, 2012

Study Completion

February 28, 2012

Last Updated

October 6, 2017

Record last verified: 2017-10

Locations

US(1)