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NCT06453265 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Abuse Potential of Intranasal Cebranopadol
A Phase 1 study, sponsored by Tris Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT06453265: Completed Phase 1 study, sponsored by Tris Pharma.
NCT06453265 is a Phase 1 study that has completed, run by Tris Pharma. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06453265, a Phase 1 study, has completed, sponsored by Tris Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
The purpose of this study to Assess the Abuse Potential of Intranasal Cebranopadol Compared to Oxycodone and Placebo in Healthy, Nondependent Recreational Opioid Users.
Primary Outcome
The primary pharmacodynamic endpoint (Drug Liking VAS Emax) will be evaluated with a linear mixed-effects model, containing treatment, period, sequence and first-order carryover as fixed effects and subject nested within sequence as random effect, using the Modified Completer Population
Interventions
- DRUG Treatment B
- DRUG Cebranopadol- 600 ug
- DRUG Cebranopadol- 800ug
- DRUG Cebranopadol- 1000ug
- DRUG Treatment A:
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2024-06-28 |
| Est. Completion | 2024-11-06 |
| Phase | Phase 1 |
What the finished NCT06453265 record still lists
NCT06453265 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 5 interventions - of which Treatment B is the first listed.
NCT06453265 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06453265 about?
NCT06453265 is a clinical study titled "A Study to Assess the Abuse Potential of Intranasal Cebranopadol". The purpose of this study to Assess the Abuse Potential of Intranasal Cebranopadol Compared to Oxycodone and Placebo in Healthy, Nondependent Recreational Opioid Users.
What is the current status of trial NCT06453265?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2024-06-28. Estimated completion is 2024-11-06.
What interventions are being tested in trial NCT06453265?
The interventions under investigation include: Treatment B (DRUG), Cebranopadol- 600 ug (DRUG), Cebranopadol- 800ug (DRUG), Cebranopadol- 1000ug (DRUG), Treatment A: (DRUG).
Who is sponsoring clinical trial NCT06453265?
This trial is sponsored by Tris Pharma, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06453265's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 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
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