Efficacy, Pharmacokinetics and Safety of Org 25969 in Subjects With Normal or Impaired Renal Function (19.4.304)(P05948)(COMPLETED)

Last updated: June 15, 2017
Sponsor: Merck Sharp & Dohme Corp.
Overall Status: Completed

Phase

3

Condition

Nephropathy

Kidney Failure

Kidney Failure (Pediatric)

Treatment

N/A

Clinical Study ID

NCT00482599
P05948
19.4.304
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to compare the efficacy and pharmacokinetics of Org 25969 in subjects with normal or impaired renal function and to evaluate the safety of Org 25969 in subjects with impaired renal function.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ASA class 1 - 3 for renally impaired patients, ASA class 1-2 for control group

  • Age at least 18 years

  • Scheduled for general anesthesia without further need for muscle relaxation other thanone single dose of 0.6 mg.kg-1 rocuronium

  • Scheduled for surgical procedures in the supine position

  • Written informed consent

  • Creatinine clearance (CLCR) < 30 mL/min for renally impaired group, CLCR = 80 mL/minfor control group

Exclusion

Exclusion Criteria:

  • Known or suspected neuromuscular disorders impairing NMB

  • Known or suspected (family) history of malignant hyperthermia

  • Known or suspected allergy to narcotics, muscle relaxants or other medication usedduring general anesthesia

  • Use of medication known to interfere with NMBA based on the dose and the time ofadministration, such as antibiotics, anticonvulsants and Mg2+

  • Pregnancy

  • Childbearing potential without using any of the following methods of birth control:condom or diaphragm with spermicide, vasectomized partner ( > 6 months), intrauterinedevice, abstinence

  • Breast-feeding

  • Prior participation in any trial with Org 25969

  • Participation in another clinical trial, not pre-approved by NV Organon, within 30days of entering into trial 19.4.304, or for the UK only: Participation in anotherclinical trial, within 30 days of entering into trial 19.4.304.

Study Design

Total Participants: 30
Study Start date:
June 01, 2005
Estimated Completion Date:
April 13, 2006