First Administration to Man Of Org 25435 a New Intravenous Anesthetic

• Status: Completed
• Trial end date: 2000-03-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Plymouth
• Collaborators: Organon Teknika; Veeda Clinical Research
• Treatments: Anesthetics; Anesthetics, Intravenous

Criteria

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.

Exclusion Criteria:

• Females

• History or evidence of clinically significant cardiovascular, respiratory, endocrine, renal, hepatic, neurological or psychiatric disease.

• History of or familial presence of malignant hyperthermia.

• Presence of any condition likely to affect the normal kinetics of the study drug.

• Requirement for prescribed medication.

• Use of concomitant medication in the 5 days prior to dosing.

• General anaesthesia within the previous 3 months.

• History of clinically significant allergy or hypersensitivity to any drug.

• History of clinically significant head injury.

• History of febrile convulsion.

• Known history of human immunodeficiency virus (HIV) infection.

• Use of investigational drug within previous three months.

• Previous administration of an investigational intravenous anaesthetic drug.

• Previous administration of Org 25435 within this study.

• History of alcohol / drug abuse.

• Average consumption of more than 20 units of alcohol a week.

• Subjects who smoke or who have smoked within the past 6 months.

• Inability to communicate with the Investigators for any reason.

• Donation of blood within one month of the study, or the intention to donate blood within one month following the study.