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

August 5, 2011
June 6, 2012
August 2011
May 2012   (final data collection date for primary outcome measure)
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.
PK Assessment [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
PK Assessment in mild and moderate 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.
Complete list of historical versions of study NCT01431833 on ClinicalTrials.gov Archive Site
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.
Safety [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Safety Assessments evaluated through adverse events, laboratory evaluations (hematology and chemistry), vital signs, ECGs, and physical examinations, in mild and moderate hepatic impairment and matched controls.
Not Provided
Not Provided
 
A PK and Safety Study in Subjects With Hepatic Impairment
A Phase 1 Open-Label Study With Oral TR-701 FA to Assess Pharmacokinetics and Safety in Subjects With Moderate or Severe Hepatic Impairment

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Hepatic Impairment
Drug: TR-701 FA
Oral single dose 200 mg
  • Experimental: Moderate hepatic
    Not applicable.
    Intervention: Drug: TR-701 FA
  • Experimental: Severe Hepatic
    Not applicable.
    Intervention: Drug: TR-701 FA
  • Experimental: Matched control
    Not applicable.
    Intervention: Drug: TR-701 FA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01431833
TR701-124
No
Trius Therapeutics, Inc.
Trius Therapeutics, Inc.
Not Provided
Study Chair: Phillippe G Prokocimer, MD Trius Therapeutics
Trius Therapeutics, Inc.
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP