Ignite Creation Date:
2025-12-18 @ 7:18 AM
Ignite Modification Date:
2025-12-18 @ 7:18 AM
Study NCT ID:
NCT00744679
Status:
None
Last Update Posted:
2015-02-10 00:00:00
First Post:
2008-08-29 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pharmacokinetic (PK) Study of Natalizumab (Tysabri) at Steady State
Sponsor:
None
Organization:
Study Overview
Official Title:
An Assessment of the Steady-State Pharmacokinetic and Pharmacodynamic Profile of Tysabri 300 mg Following at Least 12 Monthly Infusions
Status:
None
Status Verified Date:
2015-02
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 primary objective is to assess the pharmacokinetic (PK) profile of natalizumab (Tysabri) at steady state.
The secondary objective is to assess the pharmacodynamics (PD) profile (α4 integrin saturation) of Tysabri at steady state.
The secondary objective is to assess the pharmacodynamics (PD) profile (α4 integrin saturation) of Tysabri at steady state.
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?: