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A Pharmacokinetics and Safety Study in Subjects With Renal Impairment

NCT01452828 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-05-03

No results posted yet for this study

Summary

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

Conditions

  • Renal Impairment

Interventions

DRUG

TR-701 FA single infusion

Single IV infusion, 200 mg daily for 7 days

DRUG

TR-701 FA

Two separate infusions of 200 mg

DRUG

TR-701 FA

Single IV infusion, 200 mg daily for 7 days

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Philippe Prokocimer, MD · Trius Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01452828 on ClinicalTrials.gov