A Pharmacokinetics and Safety Study in Subjects With Renal Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01452828
First received: September 21, 2011
Last updated: June 7, 2012
Last verified: October 2011
  Purpose

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


Condition Intervention Phase
Renal Impairment
Drug: TR-701 FA single infusion
Drug: TR-701 FA
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Trius Therapeutics, Inc.:

Primary Outcome Measures:
  • Composite (or Profile) of Pharmacokinetics [ 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 24
Study Start Date: October 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal Impairment Nondialyzed
Not applicable
Drug: TR-701 FA single infusion
Single IV infusion, 200 mg daily for 7 days
Other Name: Tedizolid
Experimental: Renal Impairment Dialyzed
Not applicable
Drug: TR-701 FA
Two separate infusions of 200 mg
Other Name: Tedizolid
Experimental: Matched Control Drug: TR-701 FA
Single IV infusion, 200 mg daily for 7 days
Other Name: Tedizolid

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01452828

Locations
United States, Florida
Trius Investigator Site 001
Orlando, Florida, United States, 32809
United States, Minnesota
Trius Investigator Site 002
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Trius Therapeutics, Inc.
Investigators
Study Chair: Philippe Prokocimer, MD Trius Therapeutics
  More Information

No publications provided

Responsible Party: Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01452828     History of Changes
Other Study ID Numbers: TR701-123
Study First Received: September 21, 2011
Last Updated: June 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Trius Therapeutics, Inc.:
Renal Impairment

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 28, 2014