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

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

March 31, 2014

Study Completion Date

May 31, 2014

Conditions
End Stage Renal Disease
Interventions
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).

All Listed Sponsors
lead

Tetraphase Pharmaceuticals, Inc

INDUSTRY

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 | Biotech Hunter | Biotech Hunter