A Pharmacokinetics and Safety Study in Subjects With Renal Impairment

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: TR-701 FA single infusion; Drug: TR-701 FA

• Registration Number: NCT01452828
• Lead Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Brief 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.

Detailed Description

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 Timeline

• Study First Submitted: 2011-09-21
• Study Start: 2011-10
• Study First Submitted QC: 2011-10-12
• Study First Posted: 2011-10-17
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-02
• Last Update Posted: 2016-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Renal Impairment Nondialyzed	TR-701 FA single infusion	-
Renal Impairment Dialyzed	TR-701 FA	-
Matched Control	TR-701 FA	-

Primary Outcome Measures

Name	Time	Method
Composite (or Profile) of Pharmacokinetics	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	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.

Trial Locations

Locations (2)

Trius Investigator Site 001; 🇺🇸 Orlando, Florida, United States

Trius Investigator Site 002; 🇺🇸 Minneapolis, Minnesota, United States