Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-26 @ 11:17 AM
Study NCT ID:
NCT06381466
Status:
SUSPENDED
Last Update Posted:
2025-09-09
First Post:
2024-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral AZD0233 Compared With Placebo in Healthy Adult Participants.
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Phase I, Randomized, Single Blinded, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD0233 Following Single and Multiple Ascending Dose Administration in Healthy Male and Female Participants 18 to 50 Years of Age.
Status:
SUSPENDED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Adverse finding in a non-clinical, chronic toxicology study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of AZD0233 following single and multiple ascending dose (SAD and MAD) administration in healthy participants.
Detailed Description:
This is a Phase I, first time in human, single-blinded, randomized, placebo-controlled study in healthy adult male and female (of non-childbearing potential) participants performed at a single Clinical Unit.
The study will be carried out in 2 parts: Part A and Part B. Eight participants will participate in each cohort. Within each cohort, 6 participants will be randomized to receive AZD0233, and 2 participants will be randomized to receive placebo.
Part A of the study will be a sequential SAD design. Five dose levels of AZD0233 are planned to be investigated (dose 1 to dose 5), 2 (dose 3 and dose 4) of which will also be assessed in participants of Japanese descent.
Part A of the study will comprise:
* A Screening Period of maximum 26 days (Day -28 to Day -2).
* An inpatient Period of up to 7 days (Day -1 to Day 6):
* Cohorts 1A, 2A, 3A (Japanese sub-Cohort only), 4A (including a Japanese sub-Cohort), and 5A: participants will be resident at the Clinical Unit from Day -1 before study intervention administration until Day 4 (72 hours after administration of the study intervention).
* Cohort 3A \[food effect (FE)\]: Participants will be resident at the Clinical Unit from Day -1 before study intervention administration and will check-out on Day 6 (72 hours after administration of the study intervention). The impact of food intake on the PK of AZD0233 will be evaluated in the same participants in Cohort 3A after a 24-hour washout period on Day 2.
Note: Japanese sub-Cohort from Cohort 3A will not be part of the FE study.
• A Follow-up Period of 7 days after the administration of the study intervention which will consist of 1 Follow-up Visit on Day 8 for Cohorts 1A, 2A, 3A (Japanese sub-Cohort only), 4A (including a Japanese sub-Cohort), and 5A and one Follow-up Visit on Day 10 for Cohort 3A, for which participants will return to the Clinical Unit for follow-up assessments.
Part B will be a sequential MAD study. Participants will be naïve to AZD0233, i.e., will not have participated in Part A of this study. There will be 3 dose levels in 4 cohorts, including a sub-cohort of participants of Japanese descent at the highest dose.
Part B will consist of:
* A Screening Period of maximum 26 days (Day -28 to Day -2).
* An Inpatient Period of 14 days (Day -1 to Day 13): Participants will be resident at the Clinical Unit from Day -1 before study intervention administration until Day 13 (\>48 hours after administration of the last dose of study intervention in case of QD (once daily) dosing and \>36 hours after the last dose for BID (twice a day) in case of dosing).
* A Follow-up Period of 7 days after the administration of the last dose of study intervention which will consist of 2 Follow-up Visits on Day 15 and Day 17.
The study will be carried out in 2 parts: Part A and Part B. Eight participants will participate in each cohort. Within each cohort, 6 participants will be randomized to receive AZD0233, and 2 participants will be randomized to receive placebo.
Part A of the study will be a sequential SAD design. Five dose levels of AZD0233 are planned to be investigated (dose 1 to dose 5), 2 (dose 3 and dose 4) of which will also be assessed in participants of Japanese descent.
Part A of the study will comprise:
* A Screening Period of maximum 26 days (Day -28 to Day -2).
* An inpatient Period of up to 7 days (Day -1 to Day 6):
* Cohorts 1A, 2A, 3A (Japanese sub-Cohort only), 4A (including a Japanese sub-Cohort), and 5A: participants will be resident at the Clinical Unit from Day -1 before study intervention administration until Day 4 (72 hours after administration of the study intervention).
* Cohort 3A \[food effect (FE)\]: Participants will be resident at the Clinical Unit from Day -1 before study intervention administration and will check-out on Day 6 (72 hours after administration of the study intervention). The impact of food intake on the PK of AZD0233 will be evaluated in the same participants in Cohort 3A after a 24-hour washout period on Day 2.
Note: Japanese sub-Cohort from Cohort 3A will not be part of the FE study.
• A Follow-up Period of 7 days after the administration of the study intervention which will consist of 1 Follow-up Visit on Day 8 for Cohorts 1A, 2A, 3A (Japanese sub-Cohort only), 4A (including a Japanese sub-Cohort), and 5A and one Follow-up Visit on Day 10 for Cohort 3A, for which participants will return to the Clinical Unit for follow-up assessments.
Part B will be a sequential MAD study. Participants will be naïve to AZD0233, i.e., will not have participated in Part A of this study. There will be 3 dose levels in 4 cohorts, including a sub-cohort of participants of Japanese descent at the highest dose.
Part B will consist of:
* A Screening Period of maximum 26 days (Day -28 to Day -2).
* An Inpatient Period of 14 days (Day -1 to Day 13): Participants will be resident at the Clinical Unit from Day -1 before study intervention administration until Day 13 (\>48 hours after administration of the last dose of study intervention in case of QD (once daily) dosing and \>36 hours after the last dose for BID (twice a day) in case of dosing).
* A Follow-up Period of 7 days after the administration of the last dose of study intervention which will consist of 2 Follow-up Visits on Day 15 and Day 17.
Study Oversight
Has Oversight DMC:
True
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?: