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 is a Phase 1 study that was terminated before completion, run by RTI International. The registered enrollment target is 24 participants.
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.
Interventions
- DRUG JDtic
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01431586
The ClinicalTrials.gov registry entry for NCT01431586 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is RTI International, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which JDtic is the first listed.
NCT01431586 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.