Stopped: Study terminated due to discontinuation of the AZD4041 clinical development program for OUD.
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)
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Part 1a: Maximum observed drug concentration (Cmax) of AZD4041
Timeframe: Day 1 to Day 5, Day 9 to Day 22
Part 1a: Area under concentration-time curve from time 0 to infinity (AUCinf) of AZD4041
Timeframe: Day 1 to Day 5, Day 9 to Day 22
Part 1b: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: For SAE - From screening (Day -28 to Day -3), For AE - From Treatment period (Day 1) up to Follow-Up Visit [Day 7 (+ 2 days) post-dose]
Part 2: Change from baseline in Self-reported withdrawal symptoms measured by the Short Opioid Withdrawal Scale-Gossop (SOWS-G)
Timeframe: From Day 4 pre-dose value (Day 4 baseline) to last Day 4 evaluation