NCT05587998

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

A Randomized, Double-blind, Placebo-controlled, Fixed Sequence Study to Assess the Effect on Respiratory Drive of Multiple Doses of AZD4041 When Co-administered With a Single Dose of Morphine in Healthy Recreational Opioid Users

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	Morphine	Participants will receive IV dose of Morphine as stated in arm description.
DRUG	AZD4041	Participants will receive oral doses of AZD4041 as stated in arm description.
OTHER	Placebo	Participants will receive oral doses of placebo as stated in arm description.

Timeline

• Start date: 2022-08-31
• Primary completion: 2023-05-25
• Completion: 2023-05-25
• First posted: 2022-10-20
• Last updated: 2024-11-15
• Results posted: 2024-11-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study