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NCT06406400 · ClinicalTrials.gov registry record · Phase 1
Drug-Drug Interaction and Safety of AZD4041 Study (Part 1) and Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AZD4041 Study in Opioid Use Disorder (Part 2).
A Phase 1 study, sponsored by AstraZeneca.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT06406400: Clinical Trial Phase 1 study, sponsored by AstraZeneca.
NCT06406400 is a Phase 1 study that was terminated before completion, run by AstraZeneca. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06406400, a Phase 1 study, was terminated before completion, sponsored by AstraZeneca.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
The purpose of the study is to assess drug-drug interaction (DDI) and safety of AZD4041 and itraconazole in healthy participants (Part 1), and to assess efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD404 when administered with buprenorphine/buprenorphine + naloxone in participants with moderate to severe opioid use disorder (OUD)
Primary Outcome
To assess the effect of itraconazole on the PK of a AZD4041 single oral dose.
Interventions
- DRUG Hydromorphone
- DRUG Itraconazole
- DRUG Buprenorphine
- DRUG AZD4041
- DRUG Buprenorphine / Naloxone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-05-13 |
| Est. Completion | 2024-07-31 |
| Phase | Phase 1 |
Why NCT06406400 stopped before completion
NCT06406400 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 5 interventions - of which Hydromorphone is the first listed.
NCT06406400 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06406400 about?
NCT06406400 is a clinical study titled "Drug-Drug Interaction and Safety of AZD4041 Study (Part 1) and Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AZD4041 Study in Opioid Use Disorder (Part 2).". The purpose of the study is to assess drug-drug interaction (DDI) and safety of AZD4041 and itraconazole in healthy participants (Part 1), and to assess efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD404 when administered with buprenorphine/buprenorphine + naloxone in partic...
What is the current status of trial NCT06406400?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2024-05-13. Estimated completion is 2024-07-31.
What interventions are being tested in trial NCT06406400?
The interventions under investigation include: Hydromorphone (DRUG), Itraconazole (DRUG), Buprenorphine (DRUG), AZD4041 (DRUG), Buprenorphine / Naloxone (DRUG).
Who is sponsoring clinical trial NCT06406400?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06406400's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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