NCT02135302

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Tetraphase Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-02-01
• Completion: 2014-03-01
• First posted: 2014-05-09
• Last updated: 2021-12-17

Locations

3 sites across 1 country: United States