Pharmacokinetics, Safety, and Tolerability of TR-701 Free Acid (FA) in Elderly Subjects
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/8/2017 |
Start Date: | January 17, 2012 |
End Date: | February 28, 2012 |
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
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).
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).
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
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