Palifermin DDI (Drug Drug Interaction)
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
1 other identifier
interventional
45
0 countries
N/A
Brief Summary
The purpose of this study is to determine if Paliferim interacts with Heparin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy-volunteers
Started Dec 2005
Typical duration for phase_1 healthy-volunteers
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 4, 2006
CompletedFirst Posted
Study publicly available on registry
August 8, 2006
CompletedNovember 6, 2014
November 1, 2014
7 months
August 4, 2006
November 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the effect of a continuous intravenous (IV) infusion of unfractionated heparin on the single-dose pharmacokinetics (PK) of palifermin in healthy subjects.
Secondary Outcomes (2)
To evaluate the effect (activated partial thromboplastin time, aPTT) of a single dose of palifermin on unfractionated heparin pharmacodynamics [(PD), AUCaPTT, 0-6, AUCaPTT, 0-24].
To evaluate the safety and tolerability of a single 60 µg/kg intravenous dose of palifermin with or without a continuous IV infusion of heparin.
Study Arms (3)
Palifermin
ACTIVE COMPARATORA single 60µg/kg IV bolus dose of palifermin on Day 1 of the treatment period
Palifermin + Heparin
EXPERIMENTALA single 60µg/kg IV bolus dose of palifermin on Day 1 of the treatment period + unfractionated heparin for a 2 to 3 day heparin titation/maintenance period and continuing through a 3 day treatment period
Heparin
ACTIVE COMPARATORunfractionated heparin for a 2 to 3 day heparin titation/maintenance period and continuing through a 3 day treatment period
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Yang BB, Gillespie B, Smith B, Smith W, Lissmats A, Rudebeck M, Kullenberg T, Olsson B. Pharmacokinetic and pharmacodynamic interactions between palifermin and heparin. J Clin Pharmacol. 2015 Oct;55(10):1109-18. doi: 10.1002/jcph.516. Epub 2015 May 28.
PMID: 25880826DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Biovitrum AB (publ)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2006
First Posted
August 8, 2006
Study Start
December 1, 2005
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
November 6, 2014
Record last verified: 2014-11