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).

Study identifier:D7460C00004

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official Title

A Two-Part Study to Examine the Drug-Drug Interaction with Itraconazole and Safety of AZD4041 in Healthy Participants and the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AZD4041 as an Adjunctive Treatment to Buprenorphine in Participants with Moderate to Severe Opioid Use Disorder

Medical condition

Opioid Use Disorder

Phase

Phase 2

Healthy volunteers

No

Study drug

AZD4041, Itraconazole, Buprenorphine, Buprenorphine / Naloxone, Hydromorphone, Placebo

Sex

All

Estimated Enrollment

100

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 07 May 2024
Estimated Primary Completion Date: 07 May 2026
Estimated Study Completion Date: 07 May 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 May 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria