NCT01623401

A Phase 1, Open-Label, 10 Day Safety Study

Phase 1, Open-Label, Ophthalmology and Neurology Safety Study of Oral 200 mg TR-701 FA Once Daily for 10 Days in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1 open-label study in healthy volunteers who will receive oral 200 mg TR 701 FA once daily for 10 days and will include ophthalmologic and neurologic assessments.

Detailed description

This is a Phase 1 open-label study in healthy volunteers who will receive oral 200 mg TR 701 FA once daily for 10 days (Days 1 through 10) and undergo safety evaluations including ophthalmologic and neurologic assessments before (Screening or Day -1), 1 day after final study drug administration (Day 11 or earlier if a subject discontinues treatment), and 2 to 4 weeks after the last study drug administration (Late Follow-up Visit).

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	TR-701 FA	TR-701 FA 200 mg once daily

Timeline

• Start date: 2012-05-17
• Primary completion: 2012-08-24
• Completion: 2012-08-24
• First posted: 2012-06-20
• Last updated: 2017-10-06

Locations

1 site across 1 country: United States