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P021

Peptide 021, GLXC-21260

Quick Stats
Studies 37
Trials 57
Completed PHASE1 INTERVENTIONAL NCT00490737

Safety Study to Evaluate Daptomycin in Non-infected Adults Who Are Either on Hemodialysis or Continuous Ambulatory Peritoneal Dialysis (MK-3009-021)

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Interventions

Name: daptomycin
Type: DRUG
Description: 6mg/kg, i.v. infusion over 30 minutes; every 48 hours for a total of 3 doses

Primary Outcomes

Measure: Pharmacokinetics
TimeFrame: Study Day 1, 3, 5 and 7 or 8
Description:

Trial Information

NCT ID

NCT00490737

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

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

Last Updated

December 15, 2025