Track topics on Twitter Track topics that are important to you
Title: First administration to man of Org 25435, a new intravenous anaesthetic.
Clinical Phase: Phase I
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.
Synopsis Trial Number 12.4.104 Trial Title First administration to man of Org 25435 a new intravenous anesthetic Trial Center Phase 1 Clinical Trials Unit Limited, 119 Looseleigh Lane, Derriford, Plymouth PL6 5HH Publication Studied Period The first subject was screened on 04/01/2000 and the final subject completed the follow up on 24/03/2000.
Phase of Development Phase I (First into Man) Objectives To assess the safety, tolerability and efficacy of Org 25435 as an intravenous anesthetic and to obtain preliminary pharmacodynamic and pharmacokinetic details of Org 25435.
Methodology Sequential rising dose study of an intravenous anesthetic in young healthy males, at up to eight dose levels.
Number of Subjects 19 healthy male volunteers were included into the dose escalation part of the study and an additional 7 volunteers participated in the Target Controlled Infusion (TCI) part of the study.
Diagnosis and Main Criteria for Inclusion Inclusion criteria:
Good physical and mental health: absence of a clinically relevant medical history; Clinically acceptable hematology and clinical chemistry results; Hemoglobin > 13.5 g/dl; Normal ECG; Diastolic blood pressure 60 to 90 mmHg inclusive; Normal cardiac morphology demonstrated by echocardiography; Satisfactory cardiovascular response to exercise, measured by the Bruce Protocol, subjects must have completed Bruce stage 5; Aged 18 to 35 years inclusive; Body mass index (BMI) 19 to 27 inclusive, weight 65 to 100 kg inclusive; Negative hepatitis screen; Non-smoker for at least 6 months; Previous experience of general anesthesia with no problems reported; Willingness to give written informed consent; Ability to communicate well with the Investigators.
Investigational Product Dose Mode of Administration Batch Number 1 vial 200mg Org 25435 / 10ml solvent for reconstitution Intended doses: 0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 5.0 and 6.0 mg/kg Intravenous 9J521 Duration of Treatment
Dose Escalation phase:
Each study treatment consisted of an intravenous infusion of Org 25435, given by Infusion pump over exactly 1 minute.
Target Controlled Infusion phase:
Each study treatment consisted of an intravenous infusion of Org25435 given by a computer-controlled infusion over 30 minutes.
Criteria for Evaluation Tolerability, adverse events, EEG effects, cardiovascular effects, electrocardiogram (ECG), excitatory phenomena, respiratory effects, laboratory safety blood analyses, pharmacodynamic and pharmacokinetic measurements. Efficacy Induction phenomena; time of cessation of speech, eye closure, loss of eyelash reflex, eyes open on command, limb movement on command and syringe drop. Other Induction phenomena; pain on injection, sign of histamine release, excitatory phenomena, respiratory depression, apnea. Recovery phenomena; nausea / vomiting, delirium, shivering, disturbed psychomotor function, eye opening on command, spontaneous respiration, adequate respiration, move limbs on command, increased saliva production.
Statistical Methods Formal statistical methods are not appropriate in this small pilot investigative study where group sizes comprise 5 or less subjects. All data collected is presented and summarized according to investigation type (Dose Escalation or TCI).
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase 1 Clinical Trials
University of Plymouth
Published on BioPortfolio: 2014-08-27T03:16:08-0400
This stydy aims to test whether two depht-of-anaesthesia-monitors can perform equally well in monitoring anaesthetic sleep, both at induction and emergence from anaesthesia and during surg...
We aim to investigate the effectiveness and safety of nitrous oxide (N2O) in anaesthesia. Hypothesis In patients undergoing anaesthesia for major surgery, avoidance of N2O will reduce ho...
The purpose of this study is to evaluate the quantity of propofol administered with Xenon in two inspiratory concentrations, to maintain comparable depth of anaesthesia during the maintena...
Intubation may induce electromyographic (EMG) activity, causing depth of anaesthesia monitors to show misleadingly high values. The investigators want to investigate whether this EMG activ...
The use of spinal anesthesia in pre-eclamptic pregnant woman is of considerable benefit, as these patients present particular hazards with general anaesthesia, such as concerns for rapid a...
The primary objective was to assess the effect of general anaesthesia versus regional anaesthesia in a single exposure before the age of 2 years on the development of long-term behavioural changes in ...
Intraoperative awareness during general anaesthesia is rare but one of the major anaesthesia-related complications. Intraoperative awareness may be a result of inadequate anaesthesia management. There...
in elderly patients, goal directed haemodynamic therapy (GDHT), depth of anaesthesia monitoring and lung-protective ventilation have been shown to improve postoperative outcomes. The aim of this study...
Regional anaesthesia is widely used in modern anaesthetic practice for perioperative and postoperative analgesia. In the operating theatre, regional anaesthesia is used both on its own and in combinat...
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...