Overview
Safety Study to Evaluate Daptomycin in Non-infected Adults Who Are Either on Hemodialysis or Continuous Ambulatory Peritoneal Dialysis (MK-3009-021)
Status:
Completed
Completed
Trial end date:
2008-05-12
2008-05-12
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study is to examine the safety of daptomycin in patients with End Stage Renal Disease.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Cubist Pharmaceuticals LLCTreatments:
Daptomycin
Criteria
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.