NCT01431833

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 12, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 20, 2016

Status Verified

May 1, 2016

Enrollment Period

9 months

First QC Date

August 5, 2011

Last Update Submit

May 19, 2016

Conditions

Hepatic Impairment

Keywords

Hepatic ImpairmentMatched control subjects

Outcome Measures

Primary Outcomes (1)

  • 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-∞)and systemic clearance.

    7 days

Secondary Outcomes (1)

  • Safety

    7 days

Study Arms (3)

Moderate hepatic

EXPERIMENTAL
Drug: TR-701 FA

Severe Hepatic

EXPERIMENTAL
Drug: TR-701 FA

Matched control

EXPERIMENTAL
Drug: TR-701 FA

Interventions

TR-701 FADRUG

Oral single dose 200 mg

Matched controlModerate hepaticSevere Hepatic

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Trius Investigator Site 001

Orlando, Florida, 32809, United States

Location

Trius Investigator Site 002

Minneapolis, Minnesota, 55404, United States

Location

Related Publications (1)

  • Flanagan S, Minassian SL, Morris D, Ponnuraj R, Marbury TC, Alcorn HW, Fang E, Prokocimer P. Pharmacokinetics of tedizolid in subjects with renal or hepatic impairment. Antimicrob Agents Chemother. 2014 Nov;58(11):6471-6. doi: 10.1128/AAC.03431-14. Epub 2014 Aug 18.

    PMID: 25136024DERIVED

Study Officials

  • Phillippe G Prokocimer, MD

    Trius Therapeutics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2011

First Posted

September 12, 2011

Study Start

August 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 20, 2016

Record last verified: 2016-05

Locations

US(2)