This study is to examine the safety of daptomycin in patients with End Stage Renal Disease.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
6mg/kg, i.v. infusion over 30 minutes; every 48 hours for a total of 3 doses
Pharmacokinetics
Time frame: Study Day 1, 3, 5 and 7 or 8
Safety and Tolerability
Time frame: Study Days 1 through 16 or 17
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