Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-27 @ 6:53 AM
Study NCT ID:
NCT01338350
Status:
COMPLETED
Last Update Posted:
2015-01-14
First Post:
2011-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Pharmacokinetics and Pharmacodynamics After Single and Multiple Dosing of AZD5423 in Japanese Healthy Male Subjects
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled AZD5423 After Administration of Single and Multiple Ascending Doses in Healthy Male Japanese Subjects
Status:
COMPLETED
Status Verified Date:
2015-01
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 purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects (24-hours plasma cortisol area under curve, plasma cortisol pre and post ACTH stimulation, dehydroepiandrosterone sulphate (DHEAS), osteocalcin and 24 hours urine cortisol) of AZD5423 following administration of single and multiple ascending doses in healthy male Japanese subjects.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: