Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 1:01 PM
Study NCT ID:
NCT01027234
Status:
TERMINATED
Last Update Posted:
2010-05-26
First Post:
2009-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
This Study Will Assess the Safety and Tolerability of AZD8418 After Single Increasing Oral Doses
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Single-ascending Dose, First Time Into Man Study to Assess the Safety, Tolerability, and Pharmacokinetics (Part A) and an Open-label Assessment of the Effect of Food on the Pharmacokinetics (Part B) of Orally Administered AZD8418
Status:
TERMINATED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Pre-Clinical Safety Tox Findings
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 and tolerability of AZD8418 after single increasing oral doses.
Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how the study drug enters and leaves the body and how your body acts on the study drug) of AZD8418. Part B of the study will assess the effect of food on the safety and pharmacokinetics of AZD8418.
Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how the study drug enters and leaves the body and how your body acts on the study drug) of AZD8418. Part B of the study will assess the effect of food on the safety and pharmacokinetics of AZD8418.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: