First Administration to Man Of Org 25435 a New Intravenous Anesthetic

This study has been completed.
Sponsor:
Collaborators:
Veeda Clinical Research
Organon Teknika
Information provided by:
University of Plymouth
ClinicalTrials.gov Identifier:
NCT01062867
First received: February 2, 2010
Last updated: February 3, 2010
Last verified: January 2010
  Purpose

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
Anaesthesia
Drug: ORG25435
Phase 1

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

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. ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062867

Locations
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
Investigators
Study Chair: Robert Sneyd, MD University of Plymouth
  More Information

No publications provided

Responsible Party: Prof J Robert Sneyd, University of Plymouth
ClinicalTrials.gov Identifier: NCT01062867     History of Changes
Other Study ID Numbers: CT 12.4.104
Study First Received: February 2, 2010
Last Updated: February 3, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Plymouth:
Anaesthetic

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Intravenous
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, General

ClinicalTrials.gov processed this record on August 26, 2014