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

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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).

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
We found this trial at
1
site
Daytona Beach, Florida 32117
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mi
from
Daytona Beach, FL
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