A Pharmacokinetics and Safety Study in Subjects With Renal Impairment

Renal Impairment Clinical Trial

Official title:

A Phase I Open-Label Study With 200 mg Intravenous TR-701 Free Acid to Assess Safety and Pharmacokinetics in Advanced Renal Impairment Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452828
• Other study ID #: 1986-031
• Secondary ID: TR701-123
• Status: Completed
• Phase: Phase 1
• First received: September 21, 2011
• Last updated: May 2, 2016
• Start date: October 2011
• Est. completion date: March 2012

Study information

• Verified date: May 2016
• Source: Trius Therapeutics LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• TR-701 FA single infusion
Single IV infusion, 200 mg daily for 7 days
• TR-701 FA
Two separate infusions of 200 mg
• TR-701 FA
Single IV infusion, 200 mg daily for 7 days

Locations

Country	Name	City	State
United States	Trius Investigator Site 002	Minneapolis	Minnesota
United States	Trius Investigator Site 001	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Trius Therapeutics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	No