Conditions: Oral Mucositis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 44
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion arm 2: Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections arm 3: Treatment C: control group without any treatment administered.

Interventions: intervention 1: Palifermin intervention 2: Heparin
Intervention descriptions: intervention 1: 40 µg/kg IV bolus injections for three consecutive days intervention 2: Heparin continuous IV infusion

Protocol document: