drugset
drugset / Trial / NCT01062867

First Administration to Man Of Org 25435 a New Intravenous Anesthetic

NCT01062867 ↗

Phase 1 Completed 26 enrolled University of Plymouth Organon Teknika · collabVeeda Clinical Research · collab
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2000-01
Primary completion
2000-03
Completion
2000-03

Drugs

EvaluationDrugModalityDoseRoute
Subject ORG 25435 Unknown 0.25 mg/kg Intravenous
Subject ORG 25435 Unknown 0.5 mg/kg Intravenous
Subject ORG 25435 Unknown 1 mg/kg Intravenous
Subject ORG 25435 Unknown 2 mg/kg Intravenous
Subject ORG 25435 Unknown 3 mg/kg Intravenous
Subject ORG 25435 Unknown 4 mg/kg Intravenous
Subject ORG 25435 Unknown 5 mg/kg Intravenous
Subject ORG 25435 Unknown 6 mg/kg Intravenous
Subject ORG 25435 Unknown 25 mg/kg Intravenous

Indications

No indication recorded.