NCT01496677

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	TR-701 FA 200 mg	Single oral tablet of TR-701 FA to elderly subjects
DRUG	TR-701 FA 200 mg	Single oral tablet of TR-701 FA to younger group (18-45 years old)

Timeline

• Start date: 2012-01-17
• Primary completion: 2012-02-28
• Completion: 2012-02-28
• First posted: 2011-12-21
• Last updated: 2017-10-06

Locations

1 site across 1 country: United States