A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users.
Status:
Recruiting
Trial end date:
2023-02-27
Target enrollment:
Participant gender:
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 randomised to either AZD4041 and
morphine (28 participants) or placebo and morphine (16 participants). This is to ensure
completion of at least 36 subjects (24 AZD4041 + morphine, and 12 Placebo + morphine on Day
15).
The total study duration will be up to 54 days (including screening) per participant.