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

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

February 28, 2014

Study Completion Date

March 31, 2014

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.

Trial Locations (3)

32809

Orlando Clinical Research Center, Orlando

37920

New Orleans Center for Clinical Research, Knoxville

800228

Davita Clinical Research, Lakewood

All Listed Sponsors
lead

Tetraphase Pharmaceuticals, Inc

INDUSTRY

NCT02135302 - A Phase 1, Open-Label Study to Assess the Single-Dose Pharmacokinetics of Eravacycline in Subjects With Impaired Hepatic Function and Healthy Subjects | Biotech Hunter | Biotech Hunter