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).

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