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

NCT05587998 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-11-15

Study results available
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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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Debra Kelsh, MD · Altasciences Company Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2023-05-25
Completion
2023-05-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05587998 on ClinicalTrials.gov