Ignite Creation Date:
2025-12-17 @ 4:28 PM
Ignite Modification Date:
2025-12-24 @ 1:41 AM
Study NCT ID:
NCT00736658
Status:
COMPLETED
Last Update Posted:
2009-09-30
First Post:
2008-08-15
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AZD1386 Japanese Multiple Ascending Dosing Study
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Phase I, Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1386 in Healthy Japanese Young and Elderly Subjects After Oral Multiple Doses.
Status:
COMPLETED
Status Verified Date:
2009-09
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:
JMAD
Brief Summary:
This is a single centre, double-blind, randomised, parallel group, placebo controlled study to assess the safety, tolerability and pharmacokinetics of AZD1386 when given as multiple doses to 32 (24 healthy young and 8 healthy elderly) Japanese subjects. For young healthy subjects (aged ≥20 to ≤45 inclusive) 3 consecutive multiple ascending dose panels are planned. For elderly healthy subjects (aged ≥65 to≤80 inclusive) 1 multiple dose panel is planned.
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?: