A multi-center, randomized, open-label, prospective bridging, parallel dosefinding trial comparing efficacy, safety and pharmacokinetics of 4 doses of Org 25969 and placebo administered at reappearance of T2 after rocuronium or vecuronium in Japanese and Caucasian subjects. Part B: Caucasian subjects.

Conditions: ot applicable

Registration Number: EUCTR2005-001133-15-DE

Lead Sponsor: V Organon

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

1. Subjects of ASA class 1 – 3;
2. Subjects at least 20 years but under 65 years of age;
3. Caucasian subjects;
4. Subjects scheduled for elective surgery in supine position and under sevoflurane anesthesia with an anticipated duration of about 1.5-3 hours.
5. Subjects who have given written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects in whom a difficult intubation because of anatomical malformations is expected;
2. Subjects known or suspected to have neuromuscular disorders impairing NMB and/or significant renal dysfunction (for example a creatinine level > 1.6 mg/dl) and/or severe hepatic dysfunction.
3. Subjects known or suspected to have a (family) history of malignant hyperthermia;
4. Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
5. Subjects receiving medication expected to interfere with the rocuronium or vecuronium given in this trial, based on the dose and time of administration (for guidance see list in Trial Documentation File);
6. Female subjects who are pregnant;
7. Female subjects of childbearing potential not using birth control or using only oral contraception as birth control;
8. Subjects who are breast-feeding;
9. Subjects who have already participated in CT 19.4.208B, or in another trial with Org 25969;
10. Subjects who have participated in another clinical trial, not pre-approved by Organon, within 6 months of entering into CT 19.4.208B.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • To establish the dose-response relation of Org 25969 given as a reversal agent of rocuronium or vecuronium at reappearance of T2 for Caucasian subjects.;Primary end point(s): Time from start administration of Org 25969/placebo to recovery T4/T1 ratio to 0.9.;Secondary Objective: • To show equivalence of recovery of the T4/T1 ratio to 0.9 after reversal with Org 25969 administered at reappearance of T2 between Japanese and Caucasian subjects, for both rocuronium and vecuronium.<br>• To compare the pharmacokinetics and safety of single doses of Org 25969 administered in subjects of ASA 1 – 3 between Japanese and Caucasian subjects, for both rocuronium and vecuronium.

Secondary Outcome Measures