Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-29 @ 8:25 AM
Study NCT ID:
NCT01918995
Status:
COMPLETED
Last Update Posted:
2013-08-30
First Post:
2013-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repeat Dose Tolerance Study of Regadenoson in Healthy Subjects
Sponsor:
Astellas Pharma Global Development, Inc.
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Double-blind, Dose Escalation, Parallel Group, Placebo-controlled, Repeat Dose Tolerance Study of Regadenoson in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2013-08
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:
This study is to determine the safety, tolerability, and pharmacokinetics of two or three repeat intravenous (IV) bolus doses of regadenoson administered 10 minutes apart in healthy supine subjects.
Detailed Description:
All subjects will receive up to 3 doses of study drug on day 1 after fasting from all food and drink (except water) for at least 8 hours. Subjects will remain in the clinic for 2 days.
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?: