Drug-Drug Interaction and Safety of AZD4041 Study (Part 1) and Efficacy, Safety, Pharmacokinetics… (NCT06406400) | Clinical Trial Compass
TerminatedPhase 1
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).
Stopped: Study terminated due to discontinuation of the AZD4041 clinical development program for OUD.
United States15 participantsStarted 2024-05-13
Plain-language 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)
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
• Male participants:
* with female partner(s) of childbearing potential (including breastfeeding partner) must be willing to use a reliable method of contraception throughout the study period for 30 days) after final investigational medicinal product (IMP) administration for Part 1a, and for 5 drug elimination half-lives after final IMP administration for Part 1b and Part 2.
* must not donate sperm starting at screening and throughout the study period and for 30 days) after final IMP administration for Part 1a and for 5 drug elimination half-lives after final IMP administration for Part 1b and Part 2.
* with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 5 drug elimination half-lives after final IMP administration.
Part 1
* Body mass index (BMI) within 18.0 kg/m2 to 30.0 kg/m2, inclusive.
* Body weight of within 50 kg to 100 kg, inclusive.
* Non- or ex-smoker (an ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first drug administration).
Part 2
* BMI within the range of ≥ 18 and ≤ 35 kg/m2 at the screening visit.
* Participant has a diagnosis of moderate to severe OUD according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) using the Mini International Neuropsychiatric Interview (MINI) version 7.02.
* Participant is voluntarily seeking treatment for OUD.
* Partic…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1a: Maximum observed drug concentration (Cmax) of AZD4041
Timeframe: Day 1 to Day 5, Day 9 to Day 22
2
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
3
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]
4
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