A Pharmacokinetics and Safety Study in Subjects With Renal Impairment

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study is to assess the single dose pharmacokinetics (PK) and safety of TR701 FA in subjects with advance renal impairment.

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Detailed Description

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To assess the pharmacokinetics (PK) and evaluate the safety of intravenous (IV) infusion of TR-701 free acid (FA) in subjects with advanced renal impairment compared with matched control subjects with normal renal function

Conditions

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Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Renal Impairment Nondialyzed

Group Type EXPERIMENTAL

TR-701 FA single infusion

Intervention Type DRUG

Single IV infusion, 200 mg daily for 7 days

Renal Impairment Dialyzed

Group Type EXPERIMENTAL

TR-701 FA

Intervention Type DRUG

Two separate infusions of 200 mg

Matched Control

Group Type EXPERIMENTAL

TR-701 FA

Intervention Type DRUG

Single IV infusion, 200 mg daily for 7 days

Interventions

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TR-701 FA single infusion

Single IV infusion, 200 mg daily for 7 days

Intervention Type DRUG

TR-701 FA

Two separate infusions of 200 mg

Intervention Type DRUG

TR-701 FA

Single IV infusion, 200 mg daily for 7 days

Intervention Type DRUG

Other Intervention Names

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Tedizolid Tedizolid Tedizolid

Eligibility Criteria

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Inclusion Criteria

* BMI between 18.0 and 40.0 kg/m2 inclusive
* Male or female subjects between 18 and 75 years of age
* Stable dosage of medication for 30 days
* for dialysis patients, receiving chronic and stable maintenance hemodialysis for at least 3 months

Exclusion Criteria

* Functioning transplanted solid organ
* High tyramine diet
* Significant, unstable, or life-threatening condition or organ or system condition or disease, other than kidney disease in renal subjects

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No