Study to Characterize the Effect of Heparin on Palifermin Activity

Oral Mucositis Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Oral Mucositis
• Stomatitis

• NCT number: NCT01163097
• Study type: Interventional
• Source: Swedish Orphan Biovitrum
• Status: Completed
• Phase: Phase 1
• Start date: July 2010
• Completion date: January 2011