NCT00490737

Safety Study to Evaluate Daptomycin in Non-infected Adults Who Are Either on Hemodialysis or Continuous Ambulatory Peritoneal Dialysis (MK-3009-021)

An Evaluation of the Pharmacokinetic Profile and Safety and Tolerability of Multiple Doses of 6mg/kg Intravenous Daptomycin in Non-Infected Adult Subjects With End Stage Renal Disease on Hemodialysis or Continuous Ambulatory Peritoneal Dialysis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to examine the safety of daptomycin in patients with End Stage Renal Disease.

Detailed description

This is an open label, non-randomized, non-comparative Phase 1 study designed to evaluate the PK profile, safety and tolerability of intravenous ( i.v.) daptomycin. Non-infected subjects with end stage renal disease undergoing hemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD) will be enrolled in this in-patient study.

Conditions

• End-Stage Renal Disease

Interventions

Type	Name	Description
DRUG	daptomycin	6mg/kg, i.v. infusion over 30 minutes; every 48 hours for a total of 3 doses

Timeline

• Start date: 2007-08-12
• Primary completion: 2008-05-12
• Completion: 2008-05-12
• First posted: 2007-06-25
• Last updated: 2018-01-09

Regulatory

• FDA-regulated drug study