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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01431833

Enrollment

Registered

2011-09-12

Start date

2011-08-31

Completion date

2012-05-31

Last updated

2016-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Impairment

Keywords

Hepatic Impairment, Matched control subjects

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.

Interventions

DRUGTR-701 FA

Oral single dose 200 mg

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
PK Assessment	7 days	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

Measure	Time frame	Description
Safety	7 days	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026