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
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)
A Randomized, Double-blind, Placebo-controlled, Fixed Sequence Study to Assess the Effect on Respiratory Drive of Multiple Doses of AZD4041 When Co-administered With a Single Dose of Morphine in Healthy Recreational Opioid Users
This is a Phase 1, single-centre, randomized, double-blind, placebo-controlled, 2 fixed sequences, multiple dose study in healthy male and/or female recreational opioid users.
This study is being primarily conducted to assess the effect on respiratory drive of morphine administered after multiple doses of AZD4041 compared to morphine administered alone in healthy recreational opioid users.
The study will include up to 44 participants who will be randomized to either AZD4041 and morphine (28 participants) or placebo and morphine (16 participants). This is to ensure completion of at least 36 participants (24 AZD4041 + morphine, and 12 Placebo + morphine on Day 15).
The total study duration will be up to 54 days (including screening) per participant.
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of AZD4041 in Healthy Adult Subjects
This is a Phase 1, single-centre, randomized, double-blind, placebo-controlled, multiple ascending doses (MAD) study in healthy male and female adult participants.
The study will include up to 48 participants (12 participants per cohort) who will be randomized 9:3 to active drug or placebo. Each cohort will receive AZD4041 or placebo in a MAD study.
A sequential cohort MAD design will be employed to assure that higher doses are administered to healthy participants only after lower doses have demonstrated an acceptable safety profile.
The total study duration will be up to 59 days (including Screening) per participant.
100 项与 AZD-4041 相关的专利(医药)