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).

PHASE1TerminatedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

May 13, 2024

Primary Completion Date

July 31, 2024

Study Completion Date

July 31, 2024

Conditions
Opioid Use Disorder
Interventions
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.

DRUG

Buprenorphine

Participants with OUD will receive buprenorphine (as standard of care treatment) on Day 4.

DRUG

Buprenorphine / Naloxone

Participants with OUD will receive buprenorphine + naloxone (as standard of care treatment) on Days 4, 5, 6 and 7

DRUG

Hydromorphone

Participants with OUD will receive hydromorphone (as a replacement opioid) on Days 1, 2 and 3.

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."

Trial Locations (1)

21225

Research Site, Baltimore

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

AstraZeneca

INDUSTRY