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Phase 1 studies comprise the first exposure of a promising new chemical entity in healthy volunteers or, when appropriate, in patients. To assure a solid foundation for subsequent drug development, this first step must carefully assess the safety and tolerance of a new compound and often provide some indication of potential effect, so that a…

Phase I clinical studies form an important foundation for drug development and eventual approval of life-saving therapies in man. Potential drug candidates are screened for entry into Phase I trials by extensive in-vitro testing and tolerance in several animal species. Early in-vitro testing establishes potential mechanisms of action, such as binding to a receptor or…

Naltrexone is an opiate receptor antagonist typically used in the management of opioid dependence1 and alcohol addiction.2 Naltrexone is associated with a number of adverse events when administered to healthy volunteers including nausea, vomiting, and drowsiness.3 Sleep disturbances after naltrexone administration were reported in patients with opiate dependence and alcohol addiction,4Y6 obese smokers,7 and patients…