Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361348
Status:
COMPLETED
Last Update Posted:
2014-11-06
First Post:
2006-08-04
Brief Title:
Palifermin DDI Drug Drug Interaction
Sponsor:
Swedish Orphan Biovitrum
Organization:
Swedish Orphan Biovitrum
Study Overview
Official Title:
An Open-label Randomized 2-part Parallel Design Study to Characterize the Effect of Heparin on Palifermin Pharmacokinetics and the Effect of Palifermin on Heparin Pharmacodynamics in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2014-11
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 determine if Paliferim interacts with Heparin
Detailed Description:
Heparin has been shown to modulate binding of palifermin to the KGF receptor Therefore as part of a post-marketing regulatory commitment with the Food and Drug Administration FDA the purpose of this study is to characterize the potential pharmacokinetic and pharmacodynamic drug-drug interaction between a continuous IV infusion of heparin and an IV bolus injection of palifermin If an interaction is observed during co-administration it is expected that the outcome would be modulation of clearance of palifermin or a change in heparin activity Although not commonly conducted the literature describes heparin drug-drug interaction studies conducted in healthy subjects using both subcutaneous Grimaudo et al1988 Kroon et al 1992 and intravenous Caplain at al 1999 Noveck Hubbard 2004 Spowart et al 1988 formulations Based on these experiences it is appropriate to investigate heparin drug-drug interactions in healthy subjects
In this study subjects will receive a single 60 mcgkg dose of palifermin either as monotherapy or in conjunction with a continuous heparin infusion The 60 mcgkg dose of palifermin explored in this study is identical to the current recommended daily dosage for patients with hematologic malignancies who were undergoing autologous PBPC transplantation after receiving total body irradiation and high-dose chemotherapy 3 consecutive days administered in two cycles with a 5-day non-dosing interval
In this study subjects will receive a single 60 mcgkg dose of palifermin either as monotherapy or in conjunction with a continuous heparin infusion The 60 mcgkg dose of palifermin explored in this study is identical to the current recommended daily dosage for patients with hematologic malignancies who were undergoing autologous PBPC transplantation after receiving total body irradiation and high-dose chemotherapy 3 consecutive days administered in two cycles with a 5-day non-dosing interval
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