First Administration to Man Of Org 25435 a New Intravenous Anesthetic

NCT01062867 | Completed Phase 1

• 1 other identifier: CT 12.4.104
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Anaesthetic

Outcome Measures

Primary Outcomes (1)

• induction of anaesthesia (loss of consciousness)

  At time of drug administration. Recorded in minutes and seconds from the commencement of infusion.

Secondary Outcomes (1)

• recovery from anaesthesia (obey verbal commands)

  At time of drug administration. Recorded as min and sec from end of infusion

Study Arms (1)

ORG25435

EXPERIMENTAL

Infusion of intravenous anaesthetic agent to induce anaesthesia

Drug: ORG25435

Interventions

ORG25435 DRUG

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

Also known as: ORG 25435

ORG25435

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Plymouth: lead
• Veeda Clinical Research: collaborator
• Organon Teknika: collaborator

Study Sites (2)

Phase 1 Clinical Trials

Plymouth, Devon, United Kingdom

Location

Phase 1 Clinical Trials Ltd

Plymouth, United Kingdom

Location

MeSH Terms

Interventions

2-(N-bis(2-methoxyethyl)amino)butyric acid,2',6'-dimethoxyphenyl ester hydrobromide

Study Officials

• Robert Sneyd, MD

  University of Plymouth

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 4, 2010
• Study Start: January 1, 2000
• Primary Completion: March 1, 2000
• Study Completion: March 1, 2000
• Last Updated: February 4, 2010

Record last verified: 2010-01

Locations

GB (2)