NCT02135276

A Phase 1, Open-Label Study to Assess the Single-Dose Pharmacokinetics of Eravacycline in Subjects With End Stage Renal Disease and Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (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 renal impairment and healthy subjects conducted at approximately 2 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 study drug administration. Approximately 12 subjects will be enrolled: 6 subjects with ESRD and 6 healthy subjects with normal renal function. Healthy subjects will be matched to renally 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

• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	eravacycline	All subjects will receive s single dose of intravenous eravacycline (1.5 mg/kg) administered over 60 minutes on Day 1. 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 study drug administration. Approximately 12 subjects will be enrolled: 6 subjects with ESRD and 6 healthy subjects with normal renal function. Healthy subjects will be matched to renally impaired subjects in gender, age, and body mass index (BMI).

Timeline

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