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AZD4041 for Opioid Use Disorder

Phase 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Female participants must not be planning to become pregnant

Female participants must not donate ova

Must not have

Females who are lactating or pregnant

Male participants with a history of reproductive disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 5 (72 h) post dose, day 9 to day 22 (72 h) post dose

Summary

"This trial aims to see how a new drug, AZD4041, interacts with other drugs and how safe it is in healthy individuals. In addition, the study will also look at how effective and

Who is the study for?

This trial is for adults with moderate to severe opioid use disorder. Part 1 involves healthy participants to study drug interactions, while Part 2 focuses on those with OUD. Participants must not have other significant health issues that could interfere with the study.

What is being tested?

The trial has two parts: The first part tests how AZD4041 interacts with itraconazole in healthy people. The second part checks if AZD4041 is effective and safe when taken with buprenorphine or buprenorphine/naloxone by individuals with OUD.

What are the potential side effects?

Potential side effects may include typical reactions to opioids like drowsiness, constipation, nausea, and potential interaction effects from combining drugs such as increased sedation or respiratory issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not planning to become pregnant.

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I will not donate eggs during the trial.

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My BMI is between 18.0 and 30.0.

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I will not donate sperm during the study.

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I am a male weighing between 50 kg and 100 kg.

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I am a male who has never smoked or has quit smoking.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I am a male with a history of reproductive issues.

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I have a history of breathing problems or sleep disorders.

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I show signs or have symptoms of liver problems.

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I need medication that calms my nervous system.

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I need opioids to manage my chronic pain.

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My family has a history of long QT syndrome.

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I am currently infected with Hepatitis C.

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I have taken prescription medication within the last 28 days.

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I have a known kidney disease.

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I currently have cancer or have had cancer in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 5 (72 h) post dose, day 9 to day 22 (72 h) post dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 5 (72 h) post dose, day 9 to day 22 (72 h) post dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 5 (72 h) post dose, day 9 to day 22 (72 h) post dose for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Part 1a: Area under concentration-time curve from time 0 to infinity (AUCinf) of AZD4041

Part 1a: Maximum observed drug concentration (Cmax) of AZD4041

Part 1b: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Secondary study objectives

Part 1a and Part 1b: Apparent total body clearance (CL/F) of AZD4041

Part 1a and Part 1b: Apparent volume of distribution based on the terminal phase (Vz/F) of AZD4041

Part 1a and Part 1b: Area under concentration-time curve from time 0 to the last quantifiable concentration (AUClast) of AZD4041

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Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 2: AZD4041 (Dose 3)Experimental Treatment4 Interventions

Participants will receive AZD4041 (Dose 3) with hydromorphone on Days 1, 2 and 3, and buprenorphine/buprenorphine + naloxone on Days 4, 5, 6 and 7.

Group II: Part 1b: AZD4041 (Dose 2)Experimental Treatment1 Intervention

Healthy participants will receive AZD4041 (Dose 2) orally as a single dose.

Group III: Part 1a: AZD4041 (Dose 1) and ItraconazoleExperimental Treatment2 Interventions

Healthy participants will receive a single dose of AZD4041 (Dose 1) in period 1, followed by repeat dose of itraconazole for 3 days in period 2, and a single dose of AZD4041 co-administered with itraconazole on Day 9, followed by continued itraconazole daily dosing until Day 21 in period 3.

Group IV: Part 1b: PlaceboPlacebo Group1 Intervention

Healthy participants will receive matching placebo orally as a single dose.

Group V: Part 2: PlaceboPlacebo Group4 Interventions

Participants will receive matching placebo with hydromorphone on Days 1, 2 and 3, and buprenorphine/buprenorphine + naloxone on Days 4, 5, 6 and 7.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hydromorphone

2005

Completed Phase 4

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