A PK and Safety Study in Subjects With Hepatic Impairment

Hepatic Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431833
• Other study ID #: 1986-001
• Secondary ID: TR701-124
• Status: Completed
• Phase: Phase 1
• First received: August 5, 2011
• Last updated: May 19, 2016
• Start date: August 2011
• Est. completion date: May 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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• TR-701 FA
Oral single dose 200 mg

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	PK Assessment	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 (AUC0-8)and systemic clearance.	7 days	No
Secondary	Safety	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.	7 days	No