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Anaesthesia

First Administration to Man Of Org 25435 a New Intravenous Anesthetic

Sponsored by University of Plymouth

About this trial

Last updated 15 years ago

Study ID

CT 12.4.104

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
18 to 35 Years
Male
Male

Trial Timing

Ended 25 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status