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NCT05587998 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users.
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT05587998: Completed Phase 1 study, sponsored by AstraZeneca.
NCT05587998 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05587998, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
This is a Phase 1, single-centre, randomized, double-blind, placebo-controlled, 2 fixed sequences, multiple dose study in healthy male and/or female recreational opioid users. This study is being primarily conducted to assess the effect on respiratory drive of morphine administered after multiple doses of AZD4041 compared to morphine administered alone in healthy recreational opioid users. The study will include up to 44 participants who will be randomized to either AZD4041 and morphine (28 participants) or placebo and morphine (16 participants). This is to ensure completion of at least 36 participants (24 AZD4041 + morphine, and 12 Placebo + morphine on Day 15). The total study duration will be up to 54 days (including screening) per participant.
Primary Outcome
ETCo2 measurement is performed in the clinical pharmacology setting studies for the evaluation of respiratory function. EtCO2 is monitored and measured using a standardized methodology and configuration using MICROSREAM\^TM consumables to sample gas via nasal cannulae and the CAPNOSTREAM\^TM20P bedside monitor according to Altasciences SOP on Capnography. Using this configuration, for the spontaneously breathing healthy volunteer participant, baseline EtCO2 measurements is expected to fall withi
Interventions
- OTHER Placebo
- DRUG Morphine
- DRUG AZD4041
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2022-08-31 |
| Est. Completion | 2023-05-25 |
| Phase | Phase 1 |
What the finished NCT05587998 record still lists
NCT05587998 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05587998 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05587998 about?
NCT05587998 is a clinical study titled "A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users.". This is a Phase 1, single-centre, randomized, double-blind, placebo-controlled, 2 fixed sequences, multiple dose study in healthy male and/or female recreational opioid users. This study is being primarily conducted to assess the effect on respiratory drive of morphine administered after multiple d...
What is the current status of trial NCT05587998?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2022-08-31. Estimated completion is 2023-05-25.
What interventions are being tested in trial NCT05587998?
The interventions under investigation include: Placebo (OTHER), Morphine (DRUG), AZD4041 (DRUG).
Who is sponsoring clinical trial NCT05587998?
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 NCT05587998's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 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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