This is the first study to be conducted in humans for JDTic, a new chemical entity, with
evaluations focusing on the safety, tolerability, and pharmacokinetics (PK) of JDTic
following administration of single oral doses. JDTic is a novel, selective κ opioid receptor
antagonist and is currently being developed by RTI International as a potential
pharmacotherapy to treat cocaine dependence. This study has the possibility of identifying
the maximum tolerated dose in humans and a surrogate measure of JDTic pharmacodynamic (PD)
activity. Data from this study will be used to plan for and define dose ranges for subsequent
studies, as well as to identify potential indicators of JDTic pharmacological activity.