First in Humans Study of JDTic

Cocaine Dependence Clinical Trial

Official title: A Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single, Escalating Oral Doses of JDTic in Healthy Male Subjects

Status Terminated

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

• Cocaine Dependence
• Cocaine-Related Disorders

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