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First Administration to Man Of Org 25435 a New Intravenous Anesthetic

This study has been completed.
Veeda Clinical Research
Organon Teknika
Information provided by:
University of Plymouth Identifier:
First received: February 2, 2010
Last updated: February 3, 2010
Last verified: January 2010

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 Intervention Phase
Drug: ORG25435
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: First Administration to Man Of Org 25435 a New Intravenous Anesthetic

Resource links provided by NLM:

Further study details as provided by University of Plymouth:

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

Enrollment: 26
Study Start Date: January 2000
Study Completion Date: March 2000
Primary Completion Date: March 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


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.
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Prof J Robert Sneyd, University of Plymouth Identifier: NCT01062867     History of Changes
Other Study ID Numbers: CT 12.4.104
Study First Received: February 2, 2010
Last Updated: February 3, 2010

Keywords provided by University of Plymouth:

Additional relevant MeSH terms:
Anesthetics, Intravenous
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, General processed this record on April 24, 2017