Ignite Creation Date:
2024-05-06 @ 12:28 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01582399
Status:
COMPLETED
Last Update Posted:
2012-12-10
First Post:
2012-04-19
Brief Title:
Bioavailability of ASKP1240 in Healthy Subjects After Intravenous and Subcutaneous Administration of ASKP1240
Sponsor:
Astellas Pharma Global Development Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase 1 Single-Dose Parallel Group Randomized Open-Label Study to Determine the Absolute Bioavailability of ASKP1240 After Intravenous and Subcutaneous Administration in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2012-12
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 objective of this study is to assess levels of ASKP1240 in the blood after a single dose given intravenously IV or as a subcutaneous SC injection The study will determine how the drug behaves inside the body and how it is eliminated from the body by looking at the pharmacokinetics of ASP1240
In addition the study will determine the effects of ASKP1240 on the body by looking at its pharmacodynamics PD and at the safety and tolerability of ASKP1240 when given by IV or as SC injection
In addition the study will determine the effects of ASKP1240 on the body by looking at its pharmacodynamics PD and at the safety and tolerability of ASKP1240 when given by IV or as SC injection
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None