A Pharmacokinetics and Safety Study in Subjects With Renal Impairment

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

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: TR-701 FA; Drug: TR-701 FA single infusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT01452828

1986-031

TR701-123 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 24 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Renal Impairment Nondialyzed

Experimental group

Treatment:

Drug: TR-701 FA single infusion

Renal Impairment Dialyzed

Experimental group

Treatment:

Drug: TR-701 FA

Drug: TR-701 FA

Matched Control

Experimental group

Treatment:

Drug: TR-701 FA

Drug: TR-701 FA