Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368440
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-04-11
Brief Title:
A Study to Investigate the Safety and Pharmacokinetics of AZD6793 in Healthy Japanese and Chinese Participants
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Single-blind Randomized Placebo-controlled Study to Investigate the Safety Tolerability and Pharmacokinetics of an Oral Suspension of AZD6793 Following Single and Multiple Doses in Japanese and Chinese Healthy Participants
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 main purpose of this study is to assess the safety tolerability and pharmacokinetics PK of oral AZD6793 in healthy Japanese and Chinese participants
Detailed Description:
This study will be conducted to assess the safety tolerability and PK of oral AZD6793 suspension following single Part 1 and multiple Part 2 administrations in healthy Japanese and Chinese participants performed at a single Clinical Unit
Part 1 of the study will comprise
A Screening Period of maximum 28 days Day -29 to Day -2
A Treatment Period during which participants will be resident at the Clinical Unit from Day -1 until at least 72 hours after study intervention administration
A Follow-up Visit within 6 1 days after the study intervention administration
Part 2 of the study will comprise
A Screening Period of maximum 28 days Day -29 to Day -2
A Treatment Period during which participants will be resident at the Clinical Unit from Day -1 the day before first study intervention administration Day 1 until Day 10
A Follow-up Visit within 6 1 days after the last study intervention administration
Participants will be randomized to receive AZD6793 and placebo in both Part 1 and Part 2
Participants who enrolled in Part 1 will be excluded from participation in Part 2 of the study
Part 1 of the study will comprise
A Screening Period of maximum 28 days Day -29 to Day -2
A Treatment Period during which participants will be resident at the Clinical Unit from Day -1 until at least 72 hours after study intervention administration
A Follow-up Visit within 6 1 days after the study intervention administration
Part 2 of the study will comprise
A Screening Period of maximum 28 days Day -29 to Day -2
A Treatment Period during which participants will be resident at the Clinical Unit from Day -1 the day before first study intervention administration Day 1 until Day 10
A Follow-up Visit within 6 1 days after the last study intervention administration
Participants will be randomized to receive AZD6793 and placebo in both Part 1 and Part 2
Participants who enrolled in Part 1 will be excluded from participation in Part 2 of the study
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