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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01496677

Enrollment

Registered

2011-12-21

Start date

2012-01-17

Completion date

2012-02-28

Last updated

2017-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

volunteer

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 older) and younger control subjects (age 18 to 45 years).

Interventions

DRUGTR-701 FA 200 mg

Single oral tablet of TR-701 FA to elderly subjects

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Compare PK profile of TR-700 FA in elderly subjects versus younger control subjects	28 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026