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A Phase 1, Open-Label Study to Assess the Single-Dose Pharmacokinetics of Eravacycline in Subjects With Impaired Hepatic Function and Healthy Subjects

NCT02135302 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-12-17

No results posted yet for this study

Summary

This is a multi-center, open-label clinical study to assess the single-dose PK of eravacycline in subjects with hepatic impairment and healthy subjects conducted at approximately 3 sites in the United States. This study includes an up to 21-day Screening Period, a 5-day Treatment Period, and an End of Study Visit occurring approximately 2 weeks (± 2 days) after initiation of study drug administration. Approximately 24 subjects will be enrolled: 18 subjects with impaired hepatic function (6 subjects who meet the criteria for each of the 3 Child-Pugh categories of mild \[5 - 6 points\], moderate \[7 - 9 points\], and severe \[10 - 15 points\]) and 6 healthy subjects without hepatic impairment. Healthy subjects will be matched to hepatically impaired subjects in gender, age, and body mass index (BMI). All subjects will be administered a single IV dose of eravacycline (1.5 mg/kg).

Conditions

  • Impaired Hepatic Function

Interventions

DRUG

eravacycline

Eravacycline (TP-434) is a parenteral and oral antibiotic of the tetracycline class that is highly active in vitro and in established animal infection models against both nosocomial and community-acquired methicillin-susceptible or -resistant Staphylococcus aureus strains, vancomycin-susceptible or -resistant Enterococcus faecium and Enterococcus faecalis, and penicillin-susceptible or -resistant strains of Streptococcus pneumoniae. In addition, eravacycline is highly active against clinically important species of Enterobacteriaceae (including those isolates that produce extended-spectrum β-lactamases and/or are carbapenem-resistant), Acinetobacter baumannii, and anaerobes.

Sponsors & Collaborators

  • Tetraphase Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • William Smith, MD · New Orleans Center for Clinical Research

  • Thomas Marbury, MD · Orlando Clinical Research Center

  • Chris Galloway, MD · Davia Clinical Research

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-02-28
Completion
2014-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02135302 on ClinicalTrials.gov