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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01496677
First received: December 19, 2011
Last updated: June 1, 2012
Last verified: December 2011
  Purpose

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


Condition Intervention Phase
Healthy Subjects
Drug: TR-701 FA 200 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Phase 1 Open-Label Study With Oral TR-701 Free Acid to Assess Pharmacokinetics, Safety, and Tolerability in Elderly Subjects

Further study details as provided by Trius Therapeutics, Inc.:

Primary Outcome Measures:
  • Compare PK profile of TR-700 FA in elderly subjects versus younger control subjects [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: December 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elderly subjects (65 or older) Drug: TR-701 FA 200 mg
Single oral tablet of TR-701 FA to elderly subjects
Experimental: Younger adults (18-45 years old) Drug: TR-701 FA 200 mg
Single oral tablet of TR-701 FA to younger group (18-45 years old)

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496677

Locations
United States, Florida
Trius Investigator Site 001
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
Trius Therapeutics, Inc.
Investigators
Study Chair: Philippe G Prokocimer, MD Trius Therapeutics
  More Information

No publications provided

Responsible Party: Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01496677     History of Changes
Other Study ID Numbers: TR701-109
Study First Received: December 19, 2011
Last Updated: June 1, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 20, 2014