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

Phase 1

Waitlist Available

Led By Debra Kelsh, MD

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 8: predose, 0.08, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose and day 15: predose, 0.08, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours postdose

Summary

This trial tests a new drug, AZD4041, combined with morphine in healthy recreational opioid users. The goal is to see if AZD4041 changes how morphine affects breathing. Up to 44 participants will be involved, and the study will last several weeks per person. Morphine has been extensively studied for its effects on breathing, pain relief, and other physiological responses.

Eligible Conditions

Opioid Use Disorder

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 8: predose, 0.08, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose and day 15: predose, 0.08, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 8: predose, 0.08, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose and day 15: predose, 0.08, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 8: predose, 0.08, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose and day 15: predose, 0.08, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours postdose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Increased End-tidal Carbon Dioxide (EtCO2) of at Least 10 mmHg Compared to Baseline or > 50 mmHg on Day 1

Number of Participants With Increased End-tidal Carbon Dioxide (EtCO2) of at Least 10 mmHg Compared to Baseline or > 50 mmHg on Day 15

Number of Participants With Reduction in Blood Oxygen Saturation (SpO2) to < 92% on Day 1

+1 more

Secondary study objectives

Amount of AZD4041 Excreted Unchanged in Urine (Aeτ)

Apparent Fraction of AZD4041 Excreted Unchanged in Urine (Feτ/F)

Apparent Total Body Clearance at Steady State (CLss/F) of AZD4041

+45 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Morphine then AZD4041 then Morphine + AZD4041Experimental Treatment2 Interventions

Participants will receive a single intravenous (IV) dose of morphine Dose Level 1 on Day 1. From Day 2 to Day 15, participants will receive an oral dose of AZD4041 Dose Level 1, once daily for 14 consecutive days. On Day 15, participants will receive an oral dose of AZD4041 Dose Level 1 in combination with a single IV dose of morphine Dose Level 1.

Group II: Morphine then Placebo then Morphine + PlaceboPlacebo Group2 Interventions

Participants will receive a single IV dose of morphine Dose Level 1 on Day 1. From Day 2 to Day 15, participants will receive an oral dose of placebo matched to AZD4041, once daily for 14 consecutive days. On Day 15, participants will receive an oral dose of placebo matched to AZD4041 in combination with a single IV dose of morphine Dose Level 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Morphine

2013

Completed Phase 4

~2230

AZD4041

2021

Completed Phase 1

~130