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

October 4, 2017 updated by: Trius Therapeutics LLC

A Phase 1 Open-Label Study With Oral TR-701 Free Acid to Assess Pharmacokinetics, Safety, and Tolerability in Elderly Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Trius Investigator Site 001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Elderly subjects (65 or older)
Drug: TR-701 FA 200 mg
Single oral tablet of TR-701 FA to elderly subjects
Drug: TR-701 FA 200 mg
Single oral tablet of TR-701 FA to younger group (18-45 years old)
Experimental: Younger adults (18-45 years old)
Drug: TR-701 FA 200 mg
Single oral tablet of TR-701 FA to elderly subjects
Drug: TR-701 FA 200 mg
Single oral tablet of TR-701 FA to younger group (18-45 years old)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trius Therapeutics LLC

Investigators

  • Study Chair: Philippe G Prokocimer, MD, Trius Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2012

Primary Completion (Actual)

February 28, 2012

Study Completion (Actual)

February 28, 2012

Study Registration Dates

First Submitted

December 19, 2011

First Submitted That Met QC Criteria

December 20, 2011

First Posted (Estimate)

December 21, 2011

Study Record Updates

Last Update Posted (Actual)

October 6, 2017

Last Update Submitted That Met QC Criteria

October 4, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1986-028
  • TR701-109 (Other Identifier: TriusRX Unique ID)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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