Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06502379
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
A Single and Multiple Ascending Dose Study to Investigate the Safety Tolerability and Pharmacokinetics of AZD8965 in Healthy Participants Including Japanese and Chinese Participants and an Open-label Cohort to Assess the Effect of Food on the Pharmacokinetics of AZD8965 in Healthy Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Randomized Single-blind Placebo-controlled Study to Assess the Safety Tolerability and Pharmacokinetics of AZD8965 Following Single and Multiple Ascending Dose Administration to Healthy Participants Including Japanese and Chinese Participants and an Open-label Cohort to Assess the Effect of Food on the Pharmacokinetics of AZD8965 in Healthy Participants
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 PK of AZD8965 via single and multiple ascending doses in healthy participants including Japanese and Chinese participants and to assess the effect of food on the safety tolerability and PK of orally administered AZD8965
Detailed Description:
This is a first in human single and multiple ascending dose study The study consists of 4 parts Part 1 single ascending dose SAD Part 2 multiple ascending dose MAD Part 3A Japanese and Chinese SAD Part 3B Japanese and Chinese combined SAD and MAD and Part 4 Food Effect
Each study part includes a 28-day screening period and a residential period during which participants will be resident at the Clinical Unit from the day before study intervention administration Day -1 until at least 48-72 hours after the study intervention administration
Each study part includes a 28-day screening period and a residential period during which participants will be resident at the Clinical Unit from the day before study intervention administration Day -1 until at least 48-72 hours after the study intervention administration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None