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

December 19, 2011
June 1, 2012
December 2011
February 2012   (final data collection date for primary outcome measure)
Compare PK profile of TR-700 FA in elderly subjects versus younger control subjects [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01496677 on ClinicalTrials.gov Archive Site
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Pharmacokinetics, Safety, and Tolerability of TR-701 Free Acid (FA) in Elderly Subjects
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

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).

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Healthy Subjects
  • 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: Elderly subjects (65 or older)
    Intervention: Drug: TR-701 FA 200 mg
  • Experimental: Younger adults (18-45 years old)
    Intervention: Drug: TR-701 FA 200 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01496677
TR701-109
No
Trius Therapeutics, Inc.
Trius Therapeutics, Inc.
Not Provided
Study Chair: Philippe G Prokocimer, MD Trius Therapeutics
Trius Therapeutics, Inc.
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP