Study to Evaluate Daptomycin Given During Dialysis and After Dialysis

• Status: Completed
• Trial end date: 2009-07-17
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether daptomycin at a higher dose given during the last 30 minutes of a dialysis session is equal to a lower dose of daptomycin given after a dialysis session.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cubist Pharmaceuticals LLC
• Treatments: Daptomycin

Criteria

Inclusion Criteria:

• Written informed consent prior to any study-related procedure not part of normal medical care;

• Male or female ≥ 18 years of age;

• If female of childbearing potential; willing to practice reliable birth control measures during study treatment and for at least 28 days after study completion, not lactating or pregnant, and has a documented negative pregnancy test result within 24 hours prior to study medication administration;

• End-stage renal disease on stable (for at least 2 weeks) hemodialysis regimen, three times weekly using high-flux membranes;

• Functioning hemodialysis access (for example, graft or fistula);

• Considered to be in appropriate health for study entry by the Investigator (for example, no acute, debilitating medical problems) and appropriate candidate for completing study treatment;

• If taking concomitant medications, subject must be on a relatively stable dose for at least two weeks prior to study drug administration.

Exclusion Criteria:

• Received an investigational drug (including experimental biologic agents) within 30 days of study drug administration;

• Has received any dose of daptomycin within 7 days prior to study drug administration;

• Known to be allergic or intolerant to daptomycin;

• Evidence of active ongoing infection;

• Known human immunodeficiency virus (HIV) infection with CD4 count ≤ 200 cells/mm3;

• Active illicit drug use or alcohol abuse;

• Myocardial infarction within last 6 months;

• Subject with a history of muscular disease (for example, polymyositis, muscular dystrophy);

• Subject with a history of neurological disease (for example, Guillain Barré, multiple sclerosis), except stroke > 6 months prior to study entry;

• Intramuscular injection within 7 days of study drug administration;

• Body mass index (BMI) ≤ 18.5 or ≥ 40 kg/m2 (BMI = weight [kg]/height [m2]);

• WBC ≥ 12, 000 cells/mm3 or ≤ 2500 cells/ mm3;

• Neutropenic subject with absolute neutrophil count ≤ 500 cells/mm3;

• Baseline CPK values ≥ 3X ULN (upper limit of normal);

• Alanine aminotransferase (ALT) > 5XULN;

• Aspartate aminotransferase (AST) > 5XULN;

• Hemoglobin ≤ 9 gm/dL;

• Is considered unlikely to comply with study procedures or to return for scheduled post-treatment evaluations;

• History of rhabdomyolysis.