First Administration to Man Of Org 25435 a New Intravenous Anesthetic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01062867
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : February 4, 2010
Veeda Clinical Research
Organon Teknika
Information provided by:
University of Plymouth

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.

Condition or disease Intervention/treatment Phase
Anaesthesia Drug: ORG25435 Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First Administration to Man Of Org 25435 a New Intravenous Anesthetic
Study Start Date : January 2000
Actual Primary Completion Date : March 2000
Actual Study Completion Date : March 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ORG25435
Infusion of intravenous anaesthetic agent to induce anaesthesia
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
Other Name: ORG 25435

Primary Outcome Measures :
  1. induction of anaesthesia (loss of consciousness) [ Time Frame: At time of drug administration. Recorded in minutes and seconds from the commencement of infusion. ]

Secondary Outcome Measures :
  1. recovery from anaesthesia (obey verbal commands) [ Time Frame: At time of drug administration. Recorded as min and sec from end of infusion ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01062867

United Kingdom
Phase 1 Clinical Trials
Plymouth, Devon, United Kingdom
Phase 1 Clinical Trials Ltd
Plymouth, United Kingdom
Sponsors and Collaborators
University of Plymouth
Veeda Clinical Research
Organon Teknika
Study Chair: Robert Sneyd, MD University of Plymouth

Responsible Party: Prof J Robert Sneyd, University of Plymouth Identifier: NCT01062867     History of Changes
Other Study ID Numbers: CT 12.4.104
First Posted: February 4, 2010    Key Record Dates
Last Update Posted: February 4, 2010
Last Verified: January 2010

Keywords provided by University of Plymouth:

Additional relevant MeSH terms:
Anesthetics, Intravenous
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, General