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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01623401
• Other study ID #: 1986-030
• Secondary ID: TR701-110
• Status: Completed
• Phase: Phase 1
• First received: June 6, 2012
• Last updated: October 4, 2017
• Start date: May 17, 2012
• Est. completion date: August 24, 2012

Study information

• Verified date: October 2017
• Source: Trius Therapeutics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 24, 2012
• Est. primary completion date: August 24, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy males and females = 18 and = 65 years of age with no clinically significant abnormalities identified by a detailed medical history

• Female subjects must be nonpregnant, nonlactating, and either postmenopausal for at least 2 years, surgically sterile for at least 90 days, abstinent, or agree to use contraception from 1 week prior to Day -1 until 30 days after leaving the study center.

• Male subjects must be surgically sterile, abstinent, or agree to use contraception from Day -1 until 30 days after leaving the study center

• BMI = 18.0 kg/m2 and = 35.0 kg/m2

Exclusion Criteria:

• Hypersensitivity to oxazolidinones or any component in the formulation

• History or current significant ophthalmologic or neurologic condition that would adversely affect the clinical assessments or confound the interpretation of the data (e.g., dense cataracts, macular degeneration, retinitis pigmentosa)

• Positive hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibody test result

• Known genetic condition related to mitochondrial disease or dysfunction

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• TR-701 FA
TR-701 FA 200 mg once daily

Locations

Country	Name	City	State
United States	Trius Investigator Site 001	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Trius Therapeutics LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fang E, Muñoz KA, Prokocimer P. Characterization of Neurologic and Ophthalmologic Safety of Oral Administration of Tedizolid for Up to 21 Days in Healthy Volunteers. Am J Ther. 2017 Mar/Apr;24(2):e227-e233. doi: 10.1097/MJT.0000000000000534. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	The primary objective is to determine the safety of oral 200 mg TR-701 free acid (FA) administered once daily for 10 days in healthy adults. Safety outcome measures include the number and proportion of participants with adverse events, changes in vital signs and ECG, and evaluation of physical examination changes including neurologic and ophthalmologic exams.	6 weeks