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

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)0 sites12 target enrollmentAugust 12, 2007

ConditionsEnd-Stage Renal Disease

Interventionsdaptomycin

Drugsdaptomycin

Overview

Phase: Phase 1
Intervention: daptomycin
Conditions: End-Stage Renal Disease
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Enrollment: 12
Primary Endpoint: Pharmacokinetics
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 12, 2007

End Date

May 12, 2008

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Responsible Party

Sponsor

Eligibility 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;