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A PK and Safety Study in Subjects With Hepatic Impairment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01431833
First Posted: September 12, 2011
Last Update Posted: May 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Trius Therapeutics LLC
  Purpose
Assess the single dose PK and safety of TR701 FA in subjects with Moderate or Severe hepatic impairment versus matched control subjects with normal hepatic function.

Condition Intervention Phase
Hepatic Impairment Drug: TR-701 FA Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Phase 1 Open-Label Study With Oral TR-701 FA to Assess Pharmacokinetics and Safety in Subjects With Moderate or Severe Hepatic Impairment

Resource links provided by NLM:


Further study details as provided by Trius Therapeutics LLC:

Primary Outcome Measures:
  • PK Assessment [ Time Frame: 7 days ]
    PK Assessment in moderate and severe hepatic impairment and matched controls.PK Assessments include plasma parameters maximum observed concentration (Cmax), time to occurrence of Cmax, area under the plasma concentration-time curve from Hour 0 to the last measurable concentration(AUC0-t), area under the plasma concentration-time curve from Hour 0 extrapolated to infinity (AUC0-∞)and systemic clearance.


Secondary Outcome Measures:
  • Safety [ Time Frame: 7 days ]
    Safety Assessments evaluated through adverse events, laboratory evaluations (hematology and chemistry), vital signs, ECGs, and physical examinations, in moderate and severe hepatic impairment and matched controls.


Enrollment: 32
Study Start Date: August 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moderate hepatic Drug: TR-701 FA
Oral single dose 200 mg
Experimental: Severe Hepatic Drug: TR-701 FA
Oral single dose 200 mg
Experimental: Matched control Drug: TR-701 FA
Oral single dose 200 mg

Detailed Description:
This study will assess the single-dose pharmacokinetics (PK) and safety of TR-701 free acid (FA) in subjects with Moderate or Severe hepatic impairment compared with matched control subjects with normal hepatic function.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Moderate or severe hepatic impairment or matched control
  • BMI between 18.0 and 40.0 kg/m2

Exclusion Criteria:

  • Evidence of acute deterioration of hepatic function within 8 weeks
  • ALT or AST ≥ 5 times upper limit of normal for moderates; ALT or AST ≥ 8 times upper limit of normal for severes
  • Total bilirubin > 5 mg/dl for moderates; no upper limit for severes
  • Hemoglobin < 10g/dl for moderates; Hemoglobin < 9g/dl for severes
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431833


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 LLC
Investigators
Study Chair: Phillippe G Prokocimer, MD Trius Therapeutics
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Trius Therapeutics LLC
ClinicalTrials.gov Identifier: NCT01431833     History of Changes
Other Study ID Numbers: 1986-001
TR701-124 ( Other Identifier: TriusRX Unique ID )
First Submitted: August 5, 2011
First Posted: September 12, 2011
Last Update Posted: May 20, 2016
Last Verified: May 2016

Keywords provided by Trius Therapeutics LLC:
Hepatic Impairment
Matched control subjects

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Torezolid phosphate
Anti-Bacterial Agents
Anti-Infective Agents