Status:
COMPLETED
Pharmacokinetics, Safety, and Tolerability of TR-701 Free Acid (FA) in Elderly Subjects
Lead Sponsor:
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Healthy Subjects
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To compare the pharmacokinetic (PK) profile of TR-700 in elderly subjects versus younger control subjects
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 17 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2012
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01496677
Start Date
January 17 2012
End Date
February 28 2012
Last Update
October 6 2017
Active Locations (1)
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1
Trius Investigator Site 001
Daytona Beach, Florida, United States, 32117