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Drug-Drug Interaction and Safety of AZD4041 Study (Part 1) and Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AZD4041 Study in Opioid Use Disorder (Part 2).

NCT06406400 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-03-26

No results posted yet for this study

Summary

The purpose of the study is to assess drug-drug interaction (DDI) and safety of AZD4041 and itraconazole in healthy participants (Part 1), and to assess efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD404 when administered with buprenorphine/buprenorphine + naloxone in participants with moderate to severe opioid use disorder (OUD)

Conditions

Interventions

DRUG

AZD4041

Part 1a: Healthy participants will receive AZD4041 (Dose 1) orally on Day 1 and Day 9. Part 1b: Healthy participants will receive AZD4041 (Dose 2) orally on Day 1 as a single dose. Part 2: Participants with OUD will receive daily doses of AZD4041 from Days 1 to 7.

DRUG

Itraconazole

Healthy participants will receive itraconazole orally from Days 6 to 8 in Period 2 and Days 9 to 21 in Period 3.

DRUG

Buprenorphine

Participants with OUD will receive buprenorphine (as standard of care treatment) on Day 4.

DRUG

Buprenorphine / Naloxone

Participants with OUD will receive buprenorphine + naloxone (as standard of care treatment) on Days 4, 5, 6 and 7

DRUG

Hydromorphone

Participants with OUD will receive hydromorphone (as a replacement opioid) on Days 1, 2 and 3.

DRUG

Placebo

Part 1b: Healthy participants will receive matching placebo orally on Day 1 as a single dose. Part 2: Participants with OUD will receive placebo daily from Days 1 to 7.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-13
Primary Completion
2024-07-31
Completion
2024-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT06406400 on ClinicalTrials.gov