Ignite Creation Date:
2024-07-17 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491550
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Brief Title:
A Study to Assess the Safety Tolerability Pharmacokinetics and Pharmacodynamics of AZD4144 as Well as the Impact of AZD4144 on the Pharmacokinetics of Rosuvastatin in Healthy Participants
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase I Randomized Single-blind Placebo-controlled and Sequential Group Study to Assess the Safety Tolerability Pharmacokinetics and Pharmacodynamics of AZD4144 Following Single and Multiple Ascending Doses Via Intravenous Administration and an Open-label 2-Period 2-Sequence Cross-over Study to Assess the Effects of Intravenous AZD4144 on Rosuvastatin Pharmacokinetics 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:
This study consists of 3 parts Part A Part B and Part C This study will compare the safety tolerability pharmacokinetics PK and pharmacodynamics PD of AZD4144 with placebo in healthy participants in Part A and Part B Part C of this study will investigate the possibility of drug-drug interaction DDI between IV AZD4144 and oral rosuvastatin by evaluating the PK of rosuvastatin when administered alone and in combination with single IV dose of AZD4144
Detailed Description:
This is a Phase I randomized study in healthy participants and consists of 3 parts Part A Part B and Part C Part A and B are single-blind placebo-controlled with single ascending dose SAD and multiple ascending dose MAD sequential group design respectively Part C is an open-label 2-period 2-sequence cross-over design study Part A and B of the study will assess the safety tolerability PK and PD of AZD4144 solution for infusion compared with placebo while Part C will investigate the possibility of DDI between IV AZD4144 and oral rosuvastatin by evaluating the PK of rosuvastatin when administered alone and in combination with single IV dose of AZD4144
The study will comprise of
A screening period of maximum 28 days
A residential period which lasts from
Day -1 to Day 4 single dose on Day 1 for Part A
Day -1 to Day 15 dosed on days 1 4-12 for Part B
Day -1 to Day 3 dose on Day 1 and Day 9 to Day 12 dose on Day 10 for Part C
A final follow-up visit
On Day 103 for Part A
On Day 203 for Part B and C
The study will comprise of
A screening period of maximum 28 days
A residential period which lasts from
Day -1 to Day 4 single dose on Day 1 for Part A
Day -1 to Day 15 dosed on days 1 4-12 for Part B
Day -1 to Day 3 dose on Day 1 and Day 9 to Day 12 dose on Day 10 for Part C
A final follow-up visit
On Day 103 for Part A
On Day 203 for Part B and C
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