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A PK and Safety Study in Subjects With Hepatic Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01431833
First received: August 5, 2011
Last updated: June 6, 2012
Last verified: September 2011
History of Changes
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

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

Primary Outcome Measures:
  • PK Assessment [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Not applicable.
 Drug: TR-701 FA
Oral single dose 200 mg
Experimental: Severe Hepatic
Not applicable.
 Drug: TR-701 FA
Oral single dose 200 mg
Experimental: Matched control
Not applicable.
 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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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, Inc.
Investigators
Study Chair: Phillippe G Prokocimer, MD Trius Therapeutics
  More Information

No publications provided

Responsible Party: Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01431833     History of Changes
Other Study ID Numbers: TR701-124
Study First Received: August 5, 2011
Last Updated: June 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Trius Therapeutics, Inc.:
Hepatic Impairment
Matched control subjects

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013