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First Administration to Man Of Org 25435 a New Intravenous Anesthetic

NCT01062867 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2010-02-04

No results posted yet for this study

Summary

Title: First administration to man of Org 25435, a new intravenous anaesthetic.

Protocol: 12.4.104

Clinical Phase: Phase I

Study Site:

Phase I Clinical Trials Unit Ltd Old Convent of Notre Dame 119 Looseleigh Lane Plymouth PL6 5HH United Kingdom

Objectives: To assess the safety, tolerability, preliminary pharmacokinetics and efficacy of Org 25435 as an intravenous anaesthetic.

Study Design: Sequential study of an intravenous anaesthetic in young healthy males, at up to eight dose levels.

Study Drug: Org 25435, a water soluble intravenous anaesthetic.

Subjects: Up to 47 healthy male volunteers, aged 18-40 years.

Evaluations: Tolerability, adverse events, EEG effects, cardiovascular effects, electrocardiogram (ECG), excitatory phenomena, respiratory effects, laboratory safety blood analyses, pharmacodynamic and pharmacokinetic measurements.

Conditions

  • Anaesthesia

Interventions

DRUG

ORG25435

Intended doses: 0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 5.0 and 6.0 mg/kg by intravenous infusion over 1 min Up to 25mg/kg by infusion over 30min

Sponsors & Collaborators

  • Veeda Clinical Research

    collaborator INDUSTRY

  • Organon Teknika

    collaborator UNKNOWN

  • University of Plymouth

    lead OTHER

Principal Investigators

  • Robert Sneyd, MD · University of Plymouth

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-01-31
Primary Completion
2000-03-31
Completion
2000-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01062867 on ClinicalTrials.gov