Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01431586 · ClinicalTrials.gov registry record · Phase 1
First in Humans Study of JDTic
A Phase 1 study, sponsored by RTI International.
- Terminated
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01431586: Clinical Trial Phase 1 study, sponsored by RTI International.
NCT01431586 is a Phase 1 study that was terminated before completion, run by RTI International. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01431586, a Phase 1 study, was terminated before completion, sponsored by RTI International.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
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.
Primary Outcome
Safety and tolerability of JDTic: clinical signs and symptoms, adverse events (AEs), vital signs, electrocardiographic parameters, clinical laboratory test results, psychomotor function assessment
Interventions
- DRUG JDtic
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Phase | Phase 1 |
Why NCT01431586 stopped before completion
NCT01431586 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which JDtic is the first listed.
NCT01431586 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01431586 about?
NCT01431586 is a clinical study titled "First in Humans Study of JDTic". 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...
What is the current status of trial NCT01431586?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 24 participants.
What interventions are being tested in trial NCT01431586?
The interventions under investigation include: JDtic (DRUG).
Who is sponsoring clinical trial NCT01431586?
This trial is sponsored by RTI International, which has 45 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01431586's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02331979 · 24 participants · NA
Improving Bladder Function in SCI by Neuromodulation
- NCT03096197 · 24 participants · NA
Exoskeleton and Spinal Cord Stimulation for SCI
- NCT03223922 · 24 participants · NA
Neurocognitive Functioning With Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases
- NCT03326921 · 24 participants · Phase 1
HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant