A Pharmacokinetics and Safety Study in Subjects With Renal Impairment

Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)24 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Impairment

Interventions

TR-701 FA single infusionDRUG

Single IV infusion, 200 mg daily for 7 days

TR-701 FADRUG

Two separate infusions of 200 mg

TR-701 FADRUG

Single IV infusion, 200 mg daily for 7 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

Trius Investigator Site 001

Orlando, Florida, United States

Trius Investigator Site 002

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Composite (or Profile) of Pharmacokinetics

Cmax, Area Under Curve, Tmax t1/2 will be compared between each renal group and the control group, including calculation of geometric mean ratio and corresponding 90% confidence intervals.

Time frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72 hours post-dose

Data from ClinicalTrials.gov

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