First Administration to Man Of Org 25435 a New Intravenous Anesthetic
|ClinicalTrials.gov Identifier: NCT01062867|
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : February 4, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Anaesthesia||Drug: ORG25435||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||First Administration to Man Of Org 25435 a New Intravenous Anesthetic|
|Study Start Date :||January 2000|
|Primary Completion Date :||March 2000|
|Study Completion Date :||March 2000|
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
- induction of anaesthesia (loss of consciousness) [ Time Frame: At time of drug administration. Recorded in minutes and seconds from the commencement of infusion. ]
- recovery from anaesthesia (obey verbal commands) [ Time Frame: At time of drug administration. Recorded as min and sec from end of infusion ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062867
|Phase 1 Clinical Trials|
|Plymouth, Devon, United Kingdom|
|Phase 1 Clinical Trials Ltd|
|Plymouth, United Kingdom|
|Study Chair:||Robert Sneyd, MD||University of Plymouth|