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.

Inclusion Criteria:

• Written informed consent prior to any study-related procedure not part of normal medical care;
• Considered to be in appropriate health for study entry by the Investigator (e.g., no acute, debilitating medical problems) and appropriate candidate for completing study treatment;
• Male or female >18 years of age;
• If female of childbearing potential; willing to practice reliable birth control measures during study treatment, not lactating/pregnant, has a documented negative pregnancy test result within 24 hours prior to study medication administration, and willing to practice effective means of birth control for >28 days after study completion;
• If taking concomitant medications, subject must be on a relatively stable dose for at least two weeks prior to study medication administration;
• Functioning dialysis access (e.g. graft or fistula) for subjects undergoing HD and functioning dialysis access (e.g. peritoneal catheter) for subjects undergoing CAPD;
• ESRD on stable HD regimen of thrice weekly sessions with high-flux membranes or stable CAPD regimen.

Exclusion Criteria:

• If female, pregnant or lactating;
• Received an investigational drug (including experimental biologic agents) within 30 days of study entry;
• Evidence of active ongoing infection;
• Unable to discontinue use of HMG-CoA reductase inhibitor therapy for duration of study;
• Has received any dose(s) of daptomycin within 5 days prior to receiving the first dose of study drug;
• Known to be allergic or intolerant to daptomycin;
• Body Mass Index (BMI) < 18.5 or > 40 kg/m2 [BMI = weight (kg)/height (m2)];
• WBC >12, 000 cells/mm3 or <2500 cells/ mm3;
• Baseline creatinine phosphokinase (CPK) values >3X ULN (upper limit of normal);
• Alanine aminotransferase (ALT) >5X ULN;
• Aspartate aminotransferase (AST) >5X ULN;
• Known HIV-infected subjects with CD4 count ≤200 cells/mm3;
• Hemoglobin < 9 gm/dL;
• Active illicit drug and/or alcohol abuse;
• Myocardial infarction within last 6 months;
• Hospitalized for non-vascular or peritoneal dialysis (PD) access issues within 30 days;
• Subjects with a history of muscular disease (e.g., polymyositis, muscular dystrophy);
• Subjects with a history of neurological disease (e.g., Guillain Barré, multiple sclerosis), except stroke >6 months prior to study entry;
• Intramuscular injection within 7 days of study drug administration;
• Has a moribund clinical condition (i.e., high likelihood of death during the next 3 days);
• Is considered unlikely to comply with study procedures or to return for scheduled post-treatment evaluations;
• Neutropenic subjects with absolute neutrophil count ≤500 cells/mm3 History of rhabdomyolysis.

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf

http://engagezone.msd.com/ds\_documentation.php