First Administration to Man Of Org 25435 a New Intravenous Anesthetic
Title: First administration to man of Org 25435, a new intravenous anaesthetic.
Clinical Phase: Phase I
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.
|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|
- 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 ]
- 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 ]
|Study Start Date:||January 2000|
|Study Completion Date:||March 2000|
|Primary Completion Date:||March 2000 (Final data collection date for primary outcome measure)|
Infusion of intravenous anaesthetic agent to induce anaesthesia
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
|Phase 1 Clinical Trials|
|Plymouth, Devon, United Kingdom|
|Phase 1 Clinical Trials Ltd|
|Plymouth, United Kingdom|
|Study Chair:||Robert Sneyd, MD||University of Plymouth|