NCT01163097

Study to Characterize the Effect of Heparin on Palifermin Activity

An Open-label, Randomized, Parallel-Design Study to Characterize the Effect of Heparin on Palifermin Activity in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Swedish Orphan Biovitrum · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effect of a continuous intravenous infusion of unfractionated heparin on the multiple-dose pharmacodynamics of palifermin in healthy adult subjects.

Detailed description

The planned study is designed to characterize the impact of heparin on the biologic activity of palifermin and assess the impact of the combination of palifermin and heparin on tolerability. Approximately forty-three (43) eligible healthy adult men and oophorectomized or postmenopausal women between 18-45 years of age will be assigned to one of three treatment groups where treatment group A will receive a daily dose of palifermin 40 µg/kg for three consecutive days as intravenous (IV) bolus injections and continuous heparin IV infusion, treatment B will receive a daily dose of palifermin 40 µg/kg for three consecutive days as IV bolus injections and treatment C will be a control group without any treatment administered. The subjects will be randomized in a 20:15:8 ratio (Treatment A:B:C). The study consists of a up to 21-days screening period, a 5-days treatment period and a up to 45-days follow-up period.

Conditions

• Oral Mucositis

Interventions

Type	Name	Description
DRUG	Palifermin	40 µg/kg IV bolus injections for three consecutive days
DRUG	Heparin	Heparin continuous IV infusion

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-07-15
• Last updated: 2014-11-06
• Results posted: 2012-08-23

Locations

1 site across 1 country: United States