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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014