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).

NCT06406400

Phase 1 Terminated 15 enrolled AstraZeneca Parexel · collab
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

Drugs

EvaluationDrugModalityDoseRoute
Subject AZD4041 Unknown Oral
Subject Itraconazole Small molecule Oral
Background Buprenorphine Other / unclassified
Background Hydromorphone Other / unclassified
Background Naloxone Small molecule

Indications