drugset / Trial / NCT05587998

A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users.

NCT05587998

Phase 1 Completed 45 enrolled AstraZeneca
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2022-08-31
Primary completion
2023-05-25
Completion
2023-05-25

Drugs

EvaluationDrugModalityDoseRoute
Subject AZD4041 Unknown Oral
Subject Morphine Other / unclassified Intravenous