Pharmacokinetics, Safety, and Tolerability of TR-701 Free Acid (FA) in Elderly Subjects

Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Treatments

Drug: TR-701 FA 200 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01496677

1986-028

TR701-109 (Other Identifier)

Details and patient eligibility

About

To compare the pharmacokinetic (PK) profile of TR-700 in elderly subjects versus younger control subjects

Full 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).

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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