drugset / Trial / NCT06406400
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).
RandomizedSequentialTriple-blindTreatment
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)
Timeline
- Start
- 2024-05-13
- Primary completion
- 2024-07-31
- Completion
- 2024-07-31
Outcome
Outcome not reported
Stopped: “Study terminated due to discontinuation of the AZD4041 clinical development program for OUD.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AZD4041 | Unknown | — | Oral |
| Subject | Itraconazole | Small molecule | — | Oral |
| Background | Buprenorphine | Other / unclassified | — | — |
| Background | Hydromorphone | Other / unclassified | — | — |
| Background | Naloxone | Small molecule | — | — |