First Administration to Man Of Org 25435 a New Intravenous Anesthetic
Status:
Completed
Trial end date:
2000-03-01
Target enrollment:
Participant gender:
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.