Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

JDTic-001 will be a single-center, double-blind, placebo-controlled, single-dose study evaluating three planned escalating oral doses of JDTic in three planned cohorts of healthy male subjects without a history of illicit drug use within the 12 months preceding the Screening Visit, or other substances of abuse within the 12 months preceding the Screening Visit. Each cohort of up to 8 eligible subjects will be enrolled sequentially to receive a single oral dose of study drug under fasting conditions. JDTic dose escalation will occur only if safety and PK data permit. A semi adaptive dosing plan will be followed such that the first two dose cohorts will comprise 4 subjects each and the third planned cohort will comprise 8 subjects. If adverse events (AEs) considered to be at least possibly related to study medication by the Clinic Principal Investigator are noted in study subjects participating in the first two cohorts, an additional 4 subjects will be dosed at the same dose level as part of the affected cohort, unless otherwise determined by the Safety Review Team (SRT) as guided by the JDTic-001 Data and Safety Monitoring Plan (DSMP). Should dosing of additional subjects occur in the first cohort of subjects, then the second cohort of subjects will also include 8 subjects. In each cohort, subjects will be randomized 3:1 active drug: placebo in a double-blind fashion.

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. Subjects will be required to remain confined to the clinic for more than 6 nights if they experience persistent AEs that require observation and/or the Clinic Principal Investigator or qualified designee (physician who is listed as a subinvestigator on FDA Form 1572) considers it unsafe to release the subject from the clinic. Additionally, alternate subjects admitted with Group 1 but not dosed may remain in the clinic overnight for the possibility of being dosed with Group 2 and therefore would spend more than 6 nights in the clinic. Subjects will return to the clinic at 14 days after receiving their dose for a follow-up visit. If, at this visit, changes in the POMS™ assessment are noted that are considered significant in the Clinic Principal Investigator's opinion, or if a subject has an ongoing AE, the subject will return to the clinic every 14 days (or sooner, if clinically indicated) from the date of the follow-up visit until these changes/AEs have resolved. Subject participation in the study will last up to 4 weeks, from screening through the follow-up visit, depending on the date the subject's screening visit begins with respect to the date he is dosed, and provided no additional follow-up visits are necessary. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01431586
Study type Interventional
Source RTI International
Contact
Status Terminated
Phase Phase 1

See also
  Status Clinical Trial Phase
Recruiting NCT04994821 - tDCS to Reduce Craving in Cocaine Addiction- Phase 2 Study Phase 2
Completed NCT01601743 - Exercise as a Behavioral Treatment for Cocaine Dependence N/A
Completed NCT01402492 - Cocaine Use Reduction With Buprenorphine Phase 2/Phase 3
Completed NCT01176591 - HBPL Study of the Impact of the NK1 Antagonist Aprepitant Phase 2
Completed NCT00880997 - The Efficacy of Doxazosin for Cocaine Users Phase 1
Completed NCT00585520 - Sex Differences in Progesterone Effects on Responses to Stress and Drug Cues Phase 1
Completed NCT00566969 - Cocaine Withdrawal and Pharmacotherapy Response N/A
Completed NCT00368290 - Modafinil Treatment for Cocaine Dependence and HIV High-Risk Behavior Phase 2
Completed NCT00322309 - Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects Phase 2
Completed NCT00385801 - Study of the Effects of Risperdal Consta on Brain Reward Circuitry Function, Craving and Cocaine Use in Active Cocaine Dependence Phase 2
Completed NCT00167245 - Topiramate for Alcohol and Cocaine Dependence Phase 2
Completed NCT00842517 - Long Term Maintenance of Drug Abstinence Phase 1
Completed NCT04411914 - Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid Phase 1
Active, not recruiting NCT03266939 - Rebalancing the Serotonergic System in Cocaine Dependence Phase 1
Completed NCT02563769 - Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study Phase 1
Recruiting NCT06159387 - Randomized, Double-blind, Placebo-controlled Cannabis Extract x Placebo for Cocaine Addicts Phase 4
Terminated NCT02935101 - Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants Phase 2
Completed NCT02018263 - Validation of a Remote Wireless Sensor Network (WSN) Approach to the Individualized Detection of Cocaine Use in Humans Phase 1
Completed NCT01573273 - Oxytocin in Cocaine Dependence N/A
Withdrawn NCT01406522 - Tacrine Effects on Cocaine Self-Administration and Pharmacokinetics Phase 2