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

Completed · Phase 1

Conditions studied: Healthy Subjects

In brief

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

Key facts

Study ID

NCT01496677

Run by

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

People needed

28

Starts

2012-01-17

Expected to finish

2012-02-28

Last updated by the study team

2017-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Trius Investigator Site 001 — Daytona Beach, Florida, United States

Full record on ClinicalTrials.gov

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