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

NCT ID: NCT01623401

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-17

Study Completion Date

2012-08-24

Brief Summary

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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

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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

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Healthy Subjects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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TR-701 FA

TR-701 FA 200 mg oral once daily

Group Type EXPERIMENTAL

TR-701 FA

Intervention Type DRUG

TR-701 FA 200 mg once daily

Interventions

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TR-701 FA

TR-701 FA 200 mg once daily

Intervention Type DRUG

Other Intervention Names

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Tedizolid Phosphate

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe G Prokocimer, MD

Role: STUDY_CHAIR

Trius Therapeutics

Locations

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Trius Investigator Site 001

Dallas, Texas, United States

Site Status

Countries

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United States

References

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Fang E, Munoz 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.

Reference Type RESULT
PMID: 27941424 (View on PubMed)

Other Identifiers

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TR701-110

Identifier Type: OTHER

Identifier Source: secondary_id

1986-030

Identifier Type: -

Identifier Source: org_study_id