Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406400
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-06
Brief Title:
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
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 buprenorphinebuprenorphine naloxone in participants with moderate to severe opioid use disorder OUD
Detailed Description:
This study will be conducted in 2 sequential parts
Part 1 Phase I will include healthy participants and will be conducted as two separate parts Part 1a DDI cohort is an open-label fixed sequence study part which will comprise of
A Screening Period from Day -28 to Day -3
Three treatment periods
Period 1 Day -2 to Day 5 Participants will be admitted to the clinical unit on Day -2 and will receive a single oral dose of AZD4041 on Day 1 There will be a 5-day washout period
Period 2 Day 6 to Day 8 Participants will receive itraconazole for 3 days from Day 6 through Day 8
Period 3 Day 9 to Day 22 On Day 9 participants will receive single oral dose of AZD4041 co-administered with itraconazole Itraconazole alone will be administered from Day 10 to Day 21
A Follow-up Visit Participants will return to the clinical unit at least 7 days and no later than 14 days after discharge
Based on the results from Part 1a an optional part of the study Part 1b may be conducted to assess the safety tolerability and PK of AZD4041 after a single oral dose Part 1b Single Dose Cohort will be a randomized placebo-controlled double-blind participant and investigator blinded study part conducted in healthy participants This study part will comprise of the following
A Screening Period from Day -28 to Day -3
A Treatment Period Participants will be admitted to the clinical unit on Day -2 and will remain in the unit until Day 4 when they will be discharged after completion of all assessments
A Follow-up Visit Participant will return to the clinical unit at least 12 days and no greater than 16 days after the last AZD4041 PK sample
The results from Part 1 will determine the AZD4041 dose selection and safety margin to be used in Part 2
Part 2 Phase IIa will be a randomized placebo-controlled double-blind study Participants will be randomized to 1 of 2 treatment arms AZD4041 or placebo in a 11 ratio Part 2 will consist of
A Screening Period from Day -21 to Day -2
A Treatment Period Participants will be admitted to the clinical unit on Day -1 and will receive either AZD4041 or placebo with hydromorphone as a replacement opioid on Days 1 2 and 3 and buprenorphinebuprenorphine naloxone as a standard of care for their opioid withdrawal on Days 4 5 6 and 7 Participants who complete the treatment period will have continued access to Suboxone buprenorphine naloxone during their Follow-up period which will be supplied to participants at discharge Day 7
A Follow-up Visit Participant will return to the clinical unit at least 7 days and no greater than 9 days after the last AZD4041 dose
Part 1 Phase I will include healthy participants and will be conducted as two separate parts Part 1a DDI cohort is an open-label fixed sequence study part which will comprise of
A Screening Period from Day -28 to Day -3
Three treatment periods
Period 1 Day -2 to Day 5 Participants will be admitted to the clinical unit on Day -2 and will receive a single oral dose of AZD4041 on Day 1 There will be a 5-day washout period
Period 2 Day 6 to Day 8 Participants will receive itraconazole for 3 days from Day 6 through Day 8
Period 3 Day 9 to Day 22 On Day 9 participants will receive single oral dose of AZD4041 co-administered with itraconazole Itraconazole alone will be administered from Day 10 to Day 21
A Follow-up Visit Participants will return to the clinical unit at least 7 days and no later than 14 days after discharge
Based on the results from Part 1a an optional part of the study Part 1b may be conducted to assess the safety tolerability and PK of AZD4041 after a single oral dose Part 1b Single Dose Cohort will be a randomized placebo-controlled double-blind participant and investigator blinded study part conducted in healthy participants This study part will comprise of the following
A Screening Period from Day -28 to Day -3
A Treatment Period Participants will be admitted to the clinical unit on Day -2 and will remain in the unit until Day 4 when they will be discharged after completion of all assessments
A Follow-up Visit Participant will return to the clinical unit at least 12 days and no greater than 16 days after the last AZD4041 PK sample
The results from Part 1 will determine the AZD4041 dose selection and safety margin to be used in Part 2
Part 2 Phase IIa will be a randomized placebo-controlled double-blind study Participants will be randomized to 1 of 2 treatment arms AZD4041 or placebo in a 11 ratio Part 2 will consist of
A Screening Period from Day -21 to Day -2
A Treatment Period Participants will be admitted to the clinical unit on Day -1 and will receive either AZD4041 or placebo with hydromorphone as a replacement opioid on Days 1 2 and 3 and buprenorphinebuprenorphine naloxone as a standard of care for their opioid withdrawal on Days 4 5 6 and 7 Participants who complete the treatment period will have continued access to Suboxone buprenorphine naloxone during their Follow-up period which will be supplied to participants at discharge Day 7
A Follow-up Visit Participant will return to the clinical unit at least 7 days and no greater than 9 days after the last AZD4041 dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None