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First in Humans Study of JDTic

NCT01431586 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-05-10

No results posted yet for this study

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.

Conditions

  • Cocaine Dependence

Interventions

DRUG

JDtic

The planned JDTic dose levels to be evaluated are 1 mg, 3 mg, and 10 mg; however, the actual dose levels evaluated may be different, and/or additional dose levels may be added by protocol amendment, depending on the safety and PK results of the lower doses. Subjects will be admitted to the clinic the day before dosing and will be confined to the clinic for 6 nights, with safety and PK evaluations and assessments lasting approximately 125 hours following administration of study drug.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • RTI International

    lead OTHER

Principal Investigators

  • Dennis Swearingen, MD · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01431586 on ClinicalTrials.gov