First in Humans Study of JDTic

Summary

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.

Timeline

Start

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Primary completion

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Completion

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Outcome

Outcome not reported

Stopped (Enrollment): “No further subjects will be enrolled due to adverse events.”

Drugs

Indications