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

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01623401

1986-030

TR701-110 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

TR-701 FA

Experimental group

Description:

TR-701 FA 200 mg oral once daily

Treatment:

Drug: TR-701 FA