Study identifier:D7460C00004
ClinicalTrials.gov identifier:NCT06406400
EudraCT identifier:N/A
CTIS identifier:N/A
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
Opioid Use Disorder
Phase 2
No
AZD4041, Itraconazole, Buprenorphine, Buprenorphine / Naloxone, Hydromorphone, Placebo
All
100
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Oct 2024 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Part 1a: AZD4041 (Dose 1) and Itraconazole Healthy participants will receive a single dose of AZD4041 (Dose 1) in period 1, followed by repeat dose of itraconazole for 3 days in period 2, and a single dose of AZD4041 co-administered with itraconazole on Day 9, followed by continued itraconazole daily dosing until Day 21 in period 3. | Drug: AZD4041 Part 1a: Healthy participants will receive AZD4041 (Dose 1) orally on Day 1 and Day 9. Part 1b: Healthy participants will receive AZD4041 (Dose 2) orally on Day 1 as a single dose. Part 2: Participants with OUD will receive daily doses of AZD4041 from Days 1 to 7. Drug: Itraconazole Healthy participants will receive itraconazole orally from Days 6 to 8 in Period 2 and Days 9 to 21 in Period 3. Other Name: Sporanox® |
Experimental: Part 1b: AZD4041 (Dose 2) Healthy participants will receive AZD4041 (Dose 2) orally as a single dose. | Drug: AZD4041 Part 1a: Healthy participants will receive AZD4041 (Dose 1) orally on Day 1 and Day 9. Part 1b: Healthy participants will receive AZD4041 (Dose 2) orally on Day 1 as a single dose. Part 2: Participants with OUD will receive daily doses of AZD4041 from Days 1 to 7. |
Placebo Comparator: Part 1b: Placebo Healthy participants will receive matching placebo orally as a single dose. | Drug: Placebo Part 1b: Healthy participants will receive matching placebo orally on Day 1 as a single dose. Part 2: Participants with OUD will receive placebo daily from Days 1 to 7. Other Name: Placebo |
Experimental: Part 2: AZD4041 (Dose 3) Participants will receive AZD4041 (Dose 3) with hydromorphone on Days 1, 2 and 3, and buprenorphine/buprenorphine + naloxone on Days 4, 5, 6 and 7. | Drug: AZD4041 Part 1a: Healthy participants will receive AZD4041 (Dose 1) orally on Day 1 and Day 9. Part 1b: Healthy participants will receive AZD4041 (Dose 2) orally on Day 1 as a single dose. Part 2: Participants with OUD will receive daily doses of AZD4041 from Days 1 to 7. Drug: Buprenorphine Participants with OUD will receive buprenorphine (as standard of care treatment) on Day 4. Other Name: Belbuca® Drug: Buprenorphine / Naloxone Participants with OUD will receive buprenorphine + naloxone (as standard of care treatment) on Days 4, 5, 6 and 7 Other Name: Suboxone® Drug: Hydromorphone Participants with OUD will receive hydromorphone (as a replacement opioid) on Days 1, 2 and 3. Other Name: Dilaudid® |
Placebo Comparator: Part 2: Placebo Participants will receive matching placebo with hydromorphone on Days 1, 2 and 3, and buprenorphine/buprenorphine + naloxone on Days 4, 5, 6 and 7. | Drug: Buprenorphine Participants with OUD will receive buprenorphine (as standard of care treatment) on Day 4. Other Name: Belbuca® Drug: Buprenorphine / Naloxone Participants with OUD will receive buprenorphine + naloxone (as standard of care treatment) on Days 4, 5, 6 and 7 Other Name: Suboxone® Drug: Hydromorphone Participants with OUD will receive hydromorphone (as a replacement opioid) on Days 1, 2 and 3. Other Name: Dilaudid® Drug: Placebo Part 1b: Healthy participants will receive matching placebo orally on Day 1 as a single dose. Part 2: Participants with OUD will receive placebo daily from Days 1 to 7. Other Name: Placebo |