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

Tracking Information

First Received Date ^ICMJE

August 5, 2011

Last Updated Date

June 6, 2012

Start Date ^ICMJE

August 2011

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT01431833 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

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.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A PK and Safety Study in Subjects With Hepatic Impairment

Official Title ^ICMJE

A Phase 1 Open-Label Study With Oral TR-701 FA to Assess Pharmacokinetics and Safety in Subjects With Moderate or Severe Hepatic Impairment

Brief 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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Hepatic Impairment

Intervention ^ICMJE

Drug: TR-701 FA

Oral single dose 200 mg

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2012

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01431833

Other Study ID Numbers ^ICMJE

TR701-124

Has Data Monitoring Committee

Responsible Party

Trius Therapeutics, Inc.

Study Sponsor ^ICMJE

Trius Therapeutics, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Phillippe G Prokocimer, MD

Trius Therapeutics

Information Provided By

Trius Therapeutics, Inc.

Verification Date

September 2011

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

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